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Problem and Motivation. Medical device remote control technologies can enable remote experts to contribute to patient care during tele-critical care during public health emergencies like COVID-19 to address the shortage of local clinical expertise. The benefit of such technologies may be further amplified if one remote-control application can operate multiple interoperable medical devices (e.g. multiple types of ventilators or IV pumps) to support the typical diversity of deployed medical devices in one institution. However, due to the variation in capabilities of different makes/models of the same device type, this unified remote control capability requires the standardization of the data interfaces of similar devices to provide sufficient information about these devices to enable safe remote control. Method(s): Medical Device Interface Data Sheets (MDIDS) [1] can provide a useful tool for documenting current and future device interface requirements and capabilities. We examined several clinical use scenarios where externally controllable infusion pumps are used to support tele-critical care, based on which we generalized an MDIDS for remotely controllable infusion pumps. To validate this generic MDIDS, we cross-checked it with the capabilities of several externally controllable infusion pumps: the NeuroWave Accupump, Eitan Medical Sapphire, and the BD Alaris GH. Result(s): During the development of the generic remotely controllerable infusion pump MDIDS, we were able to identify the common and specific data elements that different infusion pumps need to provide at their data interfaces, considering the great diversity in these devices related to infusion mechanism, infusion programming methods, device alarms and alerts, and system settings. The resulting MDIDS includes over 100 data elements, many of which are essential for safety, including those common across different pump types (e.g., maximum settable infusion rate, occlusion alarm) and those specific to certain pump types (e.g., syringe size for syringe pumps). We developed the generic MDIDS as the theoretical basis and developed an application in our OpenICE open-source interoperability research platform [2] to remotely control the above three infusion pumps either via serial communication (representing controlling the infusion pump at a distance limited by a physical wired connection inside or outside the patient room) or across the Internet using the web extension service of OpenICE (representing situations where remote experts have no physical access to the patient). Conclusion. MDIDS for externally controllable medical devices can provide a solid basis to improve the safety and interoperability of medical device remote control technologies in the tele-critical care context. They can also benefit the research, development, and testing of physiological closed-loop control systems. We applied the MDIDS methodology to infusion pumps and ventilators to support the integration of these devices to the U.S. Army Telemedicine & Advanced Technology Research Center (TATRC) National Emergency Tele-Critical Care System.
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Introduction: Familial hyperlipidemia(FH) is a hereditary condition characterized by elevated low-density lipoprotein (LDL) levels, treated by medications and possibly apheresis when refractory. There's a rare risk of anaphylactoid reactions in 0.2-0.4%. Current literature reports apheresis reactions could be mediated by complement, bradykinin, or cytokine activation. Case Description: A 62-year-old man with FH and coronary artery disease, not taking ACE-inhibitors/ARBs, developed recurrent systemic reactions during apheresis after COVID-19 infection 1 month prior. Reactions consisted of headache, facial/tongue swelling, and oral tingling. For 7 years before his COVID-19 infection, he tolerated apheresis with a pre-medication routine of solumedrol and diphenhydramine. After the COVID-19 infection, reactions subsided after stopping the procedure. For his subsequent procedure, prednisone prior was unsuccessful at preventing reactions. For the following infusion, adjunctive prednisone, cetirizine, aspirin, montelukast administered the night prior and morning of the infusion and slowing the infusion rate to the lowest settings were unsuccessful. Complement and tryptase levels were all normal at baseline and following symptomatic treatments (Table 1) suggesting no predisposition to angioedema. Given elevated bradykinin levels are associated with LDL apheresis and these reactions, Icatibant was administered before infusion along with his routine pre-medications, and the apheresis procedure was completed without incident. Discussion(s): Limited documented cases of these reactions during LDL apheresis respond to bradykinin antagonists and none of which began after COVID-19 infection. COVID-19 is associated with significant inflammation, but rarely angioedema. Further investigation is needed as to why this FH patient is more sensitive to the effects of bradykinin after COVID-19 infection. Copyright © 2022
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INTRODUCTION: The use of ketamine as a sedative agent has increased dramatically in patients who are mechanically ventilated (MV) due to COVID-19 in intensive care units (ICU). Ketamine primarily acts as an NMDA receptor antagonist that blocks the excitatory effects of glutamate. In comparison to other sedatives, ketamine has a more favorable hemodynamic profile and does not produce significant respiratory depression. The study sought to analyze the impact of initiating ketamine continuous infusions for sedation in MV patients on co-sedation dosing. METHOD(S): This was a single-center, retrospective, observational study. All MV patients admitted to the medical intensive care unit from October 1st, 2019 to October 31st, 2021 who received ketamine continuous infusions for sedation for more than 12 hours were be eligible for inclusion. RESULT(S): Of 167 patients identified, 76 (45.5%) patients were included. The average ketamine infusion rate was 0.65 mg/kg/hr and average duration was 3.9 days. At the start of ketamine, 74 patients were on fentanyl, 27 (36.5%) of those patients were successfully weaned off fentanyl (10.8%) or had a decrease in infusion rate (25.7%). A total of 47 patients were on propofol, 39 (83%) patients were successfully weaned off propofol (55.3%) or had a decrease in infusion rate (25.7%). Seventeen patients were on midazolam infusions, of those, 12 (70.6%) patients were successfully weaned off (52.9%) or had a decrease in rate (17.6%). There were 15 patients on dexmedetomidine, 6 (40%) patients were successfully weaned off (20%) or had a decrease in infusion rate (20%). At the start of ketamine, 71 patients were on norepinephrine + vasopressin + epinephrine. Of the 71 patients, 48 (67.6%) were able to wean off vasoactive agents or had a decrease in rate. Twelve patients had documented emergence reactions or adverse reactions during infusion. CONCLUSION(S): Ketamine continuous infusion as an adjunct analgosedative agent resulted in successful weans off co-sedative agents or in decreased infusion rates. It was particularly impactful on propofol and midazolam continuous infusions as more than 50% of patients on these two agents were successfully weaned off.
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Background. Monoclonal antibodies used in the treatment and prevention of COVID 19 infection are an emerging area of infectious disease. Casirivimab/imdevimab received emergency use authorization (EUA) for the prophylaxis and treatment of COVID 19 disease. Infusion reactions may occur with the administration of monoclonal antibodies and can be relieved by slowing or stopping the infusion rate. During the casirivimab/imdevimab EUA, the National Home Infusion Foundation (NHIF) collected data to determine patient outcomes and the incidence of infusion reactions. Infusion rate and premedication protocols were also studied. Methods. Home infusion companies nationwide were invited to participate in this study by completing a short survey to determine eligibility. The data variables investigated included infusion time, adverse events, and whether standard orders for premedications were used. The data was collected using an Excel spreadsheet and a follow-up survey verified the relationship between the length of infusion and ADR incidence. The data was imported to IBM SPSS (Statistical Product and Service Solutions) for additional analysis. Results. With this patient sample, the infusion time was either 20, 30, or 50 minutes with most (62.60%) being 20 minutes (Exhibit: Infusion Time). Infusion rates were based on organization protocols, standard prescriber orders, or the clinical needs of the patient. Of the 464 patient cases, 95.26% (n=442) had no reported adverse event. Of the 22 cases with a reported event, the most common symptoms were fever (6) and hypotension (4). Premedications were not routinely included in standard prescribing orders and were based on patient specific situations. Conclusion. Administration of casirivmab/imdevimab in the home setting showed a low incidence of adverse drug reactions, and the incidence of infusion reactions were not directly related to infusion time or premedication use.
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Introduction: There are increased rates of thrombotic events such as strokes, pulmonary embolism, cutaneous and alveolar micro-thrombosis in COVID-19 patients in intensive care.1,2 Using anti-Xa, which is a direct measure of heparin activity, for dose titration leads to a greater time in therapeutic range and fewer dose adjustments than using APTTr.3 It was considered therefore that anti-Xa would be a more accurate method for monitoring heparin dosing in COVID-19 patients. Objectives: •To analyse and compare APTTr versus anti-Xa during therapeutic heparin monitoring in critical care patients with Covid-19 •To assess compliance with a new anti-Xa heparin monitoring protocol using the following standards (expected 100%). COVID-19 positive patients in critical care prescribed heparin: 1. Must have an Anti-Xa level test 5-7 hours after starting the infusion (target 6 hours) 2. Must have the correct dose alteration in response to the Anti-Xa levels 3. Must have received an adjustment of the heparin infusion rate within 2 hours of the Anti-Xa level result Methods: From April 2020 both anti-Xa levels and APTTr were run concurrently on the same blood sample for all COVID-19 positive patients receiving therapeutic unfractionated heparin on critical care. The reference ranges used were ≥0.5 to <0.8 and ≥1.5 to <2.5 respectively. The results were mapped against the respective dosing titration protocols to determine the discrepancy rate in assessing whether levels were low, in range or high for each test. Following the implementation of a new therapeutic unfractionated heparin titration protocol, using anti-Xa instead of APTTr in COVID-19 patients, an audit was conducted in these patients to determine the adherence to the new protocol. Audit data collected retrospectively April to June 2020 inclusive from Philips and ICE. Results: Therapeutic unfractionated heparin was given to 24 Covid-19 positive patients between April and December 2020 with a total of 482 samples (mean 20 samples per treatment course). The agreement rate between anti-Xa and APTTr was 44% i.e. results were both in range, both low or both high. In 35% of the paired samples the anti-Xa was judged to be in range, whereas the APTTr result suggested a dose increase was needed. The shorter audit period highlighted 13 eligible patients (59 paired samples) on therapeutic heparin during audit period. The adherence to standards 1,2 and 3 were 67%, 98% and 95% respectively. 21 sample results were excluded from standard 3 because the time of rate adjustment or acknowledgment was not recorded. For the remainder the mean time to adjustment of infusion rate following a sample being sent was 42 minutes. Conclusion: The 56% discordance rate is higher than reported elsewhere in the literature (46-49%) potentially demonstrating the effect of COVID-19 on APTTr reliability. The high rate of disagreement between the two tests suggests that if APTTr had been used for dosing in COVID-19 patients that significantly higher rates of heparin would have been used. With respect to the audit element sample timing and documentation of result acknowledgement, regardless of whether it necessitates a change in rate or not, needs to be improved.
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Background: A severe antibody-mediated inflammatory demyelinating disease of the central nervous system is neuromyelitis optica spectrum disorder (NMOSD). Azathioprine (AZA) and Rituximab (RTX) were used to treat NMO-SD patients though not FDA approved yet. Aim of the study: To compare the effectiveness and safety of rituximab treatment versus azathioprine in treating individuals with NMOSDs. Methods: Seventy four Egyptian individuals with NMOSDs in this retrospective observational study and collecting their medical records from multiple sclerosis (MS) clinics, Neurology Departments, El-Maadi Military Hospital, and Cairo University hospitals. Fourty four patients received either treatment over two year duration, Group 1 (rituximab group) consisted of 19 patients, while group 2 (azathioprine group) consisted of 25 patients. Their full medical history, general and neurological examination, MRI brain and spinal cord results, and laboratory investigation were collected including immune assays and AQP-4 antibody. Results: There was no statistically significant difference between the groups in terms of brain MRI data at the baseline and outcomes. Between the two groups, there were statistically significant differences in last observer spinal MRI (p=0.025), annual relapse rate before treatment with RTX group (P=0.021), EDSS pretreatment (p=0.005), annual relapse rate post-treatment. When it came to the number of relapses after treatment, there was a high statistically significant difference between the two groups (p=0.016), with group 1 (RTX group) having zero relapses. There was a statistically significant decrease comparing EDDS scores pre-and post-treatment regarding the RTX group (p=0.003). Adverse events were Infusion rate reaction (5.3%) and pneumonic COVID (9.5%) of patients. Conclusion: RTX is more helpful and less harmful for NMO-SD patients than AZA.
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Background: Rituximab (anti-CD20 Ab) is the cornerstone of the treatment of non-Hodgkin B lymphomas. Infusion-related reactions (IRR) are the most common adverse effects. To reduce them, intravenous premedication with antihistamine and acetaminophen is administered prior to rituximab. If no IRR after first infusion, subsequent infusions time takes 3-6 hours. Many centers use the rapid 90-minute infusion (off-label). Since 2017 subcutaneous rituximab formulation is available, that takes 5 minutes of administration. Nevertheless, in order to reduce cost, due to approval of biosimilars, some health providers continue using intravenous rituximab. On the other hand, with COVID pandemic, an effort to reduce visits and day-care hospitals stays has been made. In the current situation, it would be convenient to reduce day-care stay and the nursing care burden. We wanted to evaluate the safety of an ultrarapid infusion of biosimilar rituximab in a total time of 30 minutes by analyzing IRR and adverse events (AE). Methods: Since November 2021, 3 cohorts of ultrafast infusion have been studied as follows: One cohort (Cohort 1) with intravenous premedication with dexchlorpheniramine and acetaminophen, followed by rituximab infusion over 1 hour, and 2 cohorts with rituximab infusion over 30 minutes: Cohort 2: with intravenous premedication, and cohort 3 with oral premedication. IRR and adverse events have been independently reviewed and graded using Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 (November 27, 2017). Results: 34 patients have been included receiving 48 rituximab infusions (16 infusions in each cohort). Median age was 64 years old (range: 51-91). Diagnostic of NHL were as follows: large b cell: 10;follicular: 13;marginal: 7;mantle cell: 1, Waldeström: 1;Ritcher transformation: 2. Rituximab infusion was in monotherapy (21), and in combination (27) with: bendamustine: 9, CHOP: 17, GEMOX: 1. Considering safety, no IRR has been observed in cohort 1 (1 hour infusion), and 1 IRR grade II in cohort 3 (30 minutes, oral premedication). Other AE were: hypertension grade I and hypotension grade I, both in cohort 2. Conclusions: Ultrarapid rituximab infusion is safe. Oral premedication is feasibly allowing a total infusion time of 30 minutes. This infusion rate alleviates day-care burden saving between 75-90% of time in each rituximab infusion, reduce day-care stay and is comfortable for the patients.
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Background: The use of intermittent infusion of Levosimendan (L) demonstrated to be able to reduce hospitalisations and to improve functional capacity and quality of life in patients with advanced heart failure (HF). Purpose: To describe our preliminary experience regarding L intermittent infusions in advanced HF older outpatients. Methods: A maximum of three consecutive L infusions were carried out 14 days apart. The duration of each session was 8 hours. The starting infusion rate was 0.05 μg/Kg/min, titrated every 30/60' up to a maximum of 0.2 μg/Kg/min based on blood pressure, heart rate and arrhythmias recorded during telemetry. We evaluated patients by clinical, laboratory and echocardiographic controls at baseline and two weeks after the end of treatment. Results: Since November 2020 we enrolled 17 patients with a mean age of 77 years;12% were women. HF etiology was ischemic in 64% of cases and the mean ejection fraction was 30%. A total of 41 infusions were performed, the mean dose of L administered was 5.4 mg/infusion. Three patients did not complete the expected treatment, one due to an intercurrent COVID-19 infection and two because of social issues. In 28 sessions the maximum infusion rate was reached, while in 12 a lower rate;in one case drug infusion was suspended (Figure 1). The main complication observed was marked non-symptomatic hypotension, followed by the onset of atrial fibrillation or frequently ventricular extrasystole. As shown in Figure 2, at the end of the infusion cycles, there was an improvement of clinical and hemodynamic parameters. Moreover, at the end of the infusion cycles, we observed a reduction in the mean dose of loop diuretic prescribed and an increase in the prescription of disease- modify treatment, according to HF guidelines (Figure 3). Conclusions: In our preliminary experience repeated infusions of L appear to be well tolerated in older patients with advanced HF. Although there was an improvement in congestion parameters and targeted therapy for HF, more data will be needed in the future to confirm its safety and efficacy, also in terms of guidelines-directed medical therapy. (Figure Presented).
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Introduction: The COVID-19 pandemic has advanced market awareness of the benefits of remote-controlled ventilators to reduce the exposure of healthcare workers to patients with COVID-19, enable more rapid and frequent ventilator setting adjustment, and preserve limited personal protective equipment. The US FDA permitted manufacturers to add remote monitoring and control capabilities to ventilators and infusion pumps through immediate in effect guidance [1,2]. When integrated with tele-critical care systems, remote control of medical devices allows distant clinical experts to collaborate with local clinicians to “virtually” manage the therapy of patients at hotspots. Core remote control capabilities can also be used by software applications to implement medical device control algorithms for Software as a Medical Device (SaMD). The US Army /TATRC launched the National Tele-Critical Care Network (NETCCN) to rapidly develop and deploy a platform to support COVID-19 disaster response [3]. We are investigating technical solutions, communication protocols, and safety assurance measures for integrating remote control of medical devices to the NETCCN systems. Methods: We developed an architecture and a prototype system (Figure 1) to investigate safety, security, and interoperability requirements for integration of remote control of medical devices with tele-critical care systems. The prototype system is based on OpenICE [4], an open-source interoperability platform developed by our program to transmit data and control medical devices at the patient's bedside. Customized interfaces (hardware and software) translate device proprietary protocols to ISO/IEEE 11073-10101 terminology over DDS middleware. Remote control applications of devices connected to OpenICE are implemented as either stand-alone OpenICE apps, which can be deployed inside or immediately outside the patient's room, or as web-based apps, which can be launched from any location to communicate with the OpenICE system. We refer to the former as “nearpatient remote control”, which may be at the bedside or co-located outside the room, and the latter as “far remote” control where the operator does not have physical access to the patient or medical equipment. Our prototype system uses the RTI Web Integration Service [5] to enable web-based control applications to communicate with the connected devices. Results: The generic architecture in Figure 1 is device agnostic: it can be used with critical care ventilators, IV infusion pumps, and other devices, provided that the device interfaces support remote control. As a proof of concept, we applied this architecture to a Q Core Sapphire IV infusion pump using a non-clinical control interface, and confirmed that the infusion rate could be adjusted by both near-patient and far remote (web) control applications with generally acceptable delays (3∼8 seconds from remote control action until the pump executes the change). This prototype system allows the exploration and validation of risks associated with medical device remote control in the tele-critical care context. An example of a risk identified in our study relates contention between near and far “loci of control”. Unexpected device behavior can occur if there is no mechanism to 1) explicitly prioritize loci of control that may occur simultaneously (e.g., always prioritize local control over far control to enable the local provider to regain control or prevent remote control);and 2) clearly indicate where the locus of control resides. Other risks may arise due to issues related to cybersecurity, network QoS, permission for remote control, and usability (e.g., use errors associated with far remote control due to the lack of a real-time view of the patient). We are collaborating with the AAMI InterOperability Working Group (IOWG) to share the experience and lessons learned in this effort to develop a safety standard for medical device remote control, and with other performers in the NETCCN portfolio. (Figure Presented).
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INTRODUCTION: Propofol has been widely used in the ICU for sedation and refractory status epilepticus. PRIS is a serious and potentially fatal condition that is characterized by a spectrum of clinical symptoms and abnormalities. Literature suggests that a longer duration of propofol ≥ 48 hours or a dose ≥ 83 mcg/kg/min is associated with a higher risk of PRIS. Many of the critically ill patients in our health system required a larger dose of propofol and prolonged duration of infusion for sedation in the ICU, especially during Covid-19. Delayed treatment of PRIS can lead to death. It is very likely that patients who develop PRIS may often go unrecognized as the manifestations of PRIS can overlap with common ICU conditions. The current prevalence of PRIS is unknown, however, a prospective study has reported a prevalence of 1.1% in critically ill patients. METHODS: Patients were identified by querying the NYU Langone Health COVID clinical data mart from March 2020 till February 2021. The inclusion criteria included patients receiving propofol infusion for ≥ 48 hours or receiving a dose ≥ 60 mcg/kg/min for more than 24 hours. Pregnant patients, children, and patients with rhabdomyolysis prior to the start of infusion were excluded. PRIS was defined by the development of metabolic acidosis and cardiac dysfunction with 2 or more minor criteria (rhabdomyolysis, hypertriglyceridemia, renal failure, and hepatic transaminitis) or developing 3 or more minor criteria. RESULTS: 424 patients were included in our study. Of the 424 patients, 21 patients were found to have developed PRIS. The occurrence of PRIS was observed at the median infusion rate of 36.1 mcg/kg/min and a median duration of infusion of 147 hours. The prevalence of PRIS was found to be 4.9%. CONCLUSIONS: The prevalence of PRIS in our study was found to be 4.9%. The occurrence of PRIS was observed at the median infusion rate of 36.1 mcg/kg/min suggesting that PRIS can be developed at a lower rate of infusion than previously reported. We suggest that patients - especially those receiving a duration ≥ 48 hours and a higher dose of 60 mcg/kg/min - should be monitored for signs and symptoms of PRIS during propofol infusion as it may be underrecognized because PRIS is characterized by multiple clinical manifestations that overlap with critical illness.
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INTRODUCTION/HYPOTHESIS: Prolonged exposure to opioids through analgosedation may lead to iatrogenic opioid withdrawal syndrome (IWS) once patients are extubated and weaned from sedation. With the lack of validated assessment tools, IWS is likely underdiagnosed in critically ill adult patients. METHODS: This was an IRB-approved, prospective, observational study assessing IWS based on Clinical Opiate Withdrawal Scale (COWS) from October 2019 to November 2020. Patients were included if they were ≥18 years, admitted to the critical care medicine (CCM) service, and received ≥24 hours of continuous opioid infusion. Patients were excluded if they were admitted for drug overdose, intracranial pathology, active COVID-19, transitioned to withdrawal of life support or hospice, remained GCS ≤8 and/or RASS < -2 throughout assessment period, prisoners, pregnant patients, or missing ≥2 assessments. Patients were assessed within 24 hours from opioid cessation and followed for 5 days. The primary outcome was the incidence of at least moderate IWS diagnosis assessed using COWS. Secondary outcomes included the incidence of mild IWS based on COWS, the incidence of IWS diagnosis based on a positive DSM-V score, the correlation between diagnosis of IWS by DSM-V and COWS, and the identification of risk factors for IWS. RESULTS: Ninety-two patients were included in the final analysis. Except for a higher prevalence of psychiatric history in the IWS-positive group, baseline characteristics were similar. Overall, 11 patients (12%) developed at least moderate IWS, based on COWS. There was a strong, positive correlation between DSM-V and COWS on the day COWS was the highest (rs(90)=0.64;p< 0.01). The IWSpositive group also had longer durations of opioid infusions, higher cumulative opioid infusion doses, higher mean daily doses, and higher infusion rates at any given time. No significant differences were found between the two groups for scheduled or PRN opioids after cessation of the opioid infusion. Logistic regression did not identify any independent predictors for the development of IWS. CONCLUSION: At least 12% of CCM patients who received ≥24 hours of continuous opioid infusions developed IWS. These patients had significantly longer durations, higher cumulative daily and total opioid doses, and higher opioid infusion rates.
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INTRODUCTION: Critically ill adult patients requiring extracorporeal membrane oxygenation (ECMO) with prolonged paralytic exposure may develop potential tachyphylaxis. This phenomenon has yet to be described within the ECMO literature. DESCRIPTION: A 49-year-old male (70 kg) with hyperlipidemia and recently diagnosed COVID19, was admitted to the ICU for acute respiratory distress syndrome, intubated and paralyzed, and subsequently initiated on VV ECMO. By day 20, his sedation and paralytic regimen consisted of the following: hydromorphone 6 mg/hr, midazolam 12 mg/hr, phenobarbital IV 120 mg twice daily, and cisatracurium 12 mcg/kg/min, which was gradually increased from 5 mcg/kg/min from the previous 7 days. Propofol use was limited because of hypertriglyceridemia. Despite this, he was dyschronous with the ventilator and had 4/4 twitches on a train of four (TOF), with stable hemodynamics. A recommendation was made to stop cisatracurium and switch to rocuronium given concern for paralytic tachyphylaxis. The cisatracurium drip was stopped and the patient was loaded with a 1.2 mg/ kg (85 mg) rocuronium bolus using total body weight (TBW), followed by an 8 mcg/kg/min infusion. After 24 hours of use, the patient was more synchronous, had 0/4 twitches on a TOF, and did not require any escalation in the rocuronium infusion rate. This effect persisted for several days thereafter. DISCUSSION: This case highlights the phenomenon of paralytic tachyphylaxis in the ECMO population and sheds light on pharmacokinetic (PK) considerations. While the specific mechanism of resistance is not clearly understood, case reports in non-ECMO patients suggest that the likelihood of tachyphylaxis increases with high doses (≥12 mcg/kg/min) and prolonged use (> 7 days). Management included stopping the initial paralytic and switching to an alternative agent. Rocuronium is a hydrophilic drug with limited protein binding. Given this PK profile, we anticipated that the degree of sequestration in the ECMO circuit would be relatively low. Following our experience, we concluded that the switch to rocuronium was safe and effective in minimizing tachyphylaxis. Dosing of rocuronium may be similar to non- ECMO patients and should be guided by ventilator synchrony and TOF monitoring.
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The introduction of enzyme replacement therapy (ERT) has revolutionized the management of patients with Gaucher disease (GD). To improve the patients' quality of life, we have studied and published the safety and efficacy of a rapid 10-min infusion of high-dose velaglucerase-alfa, instead of one hour as labeled, in 15 previously treated patients. We herein present the 18-month results of the investigator-initiated research in naïve patients with GD (defined by at least one year off ERT or SRT). All patients received bi-weekly infusions of 60 unit/kgBW velaglucerase-alfa;the infusion rate was gradually reduced from 60 to 10 min over six infusions in the hospital setup, followed by home infusions. Each infusion was followed for safety, and efficacy parameters were assessed every 3 months. We enrolled 15 patients (77% males) at a median age (range) of 40 (10–72) years. Thirteen patients were never treated, and two patients were off-ERT for over one year. Ten-minute rapid infusions were well tolerated with no reported related severe or non-severe adverse events (AEs). Two patients reported a non-related SAE and another a non-related AE. Two patients dropped out due to unwillingness to attend follow-up visits during the COVID-19 pandemic. In addition, in 3 patients the infusion rate was increased back to 30 or 60 min due to different causes (2 due to sub-optimal response and one due to AE). All 13 remaining patients reached the 18-month time-point. The platelet counts increased by a median (range) of 75.1% [15.6%–206.9%] and the lyso-GB1 levels decreased by 60.15% [25.7%–85.6%]. Shortening the infusion time has shown to be safe and effective in both previously treated (Zimran et al., AJH2018) and in treatment-naïve patients (this report) and could therefore improve the quality-of-life of patients with GD who have a long-life commitment to this therapy.
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This mixed-methods quality-improvement (QI) project had the dual aims of improving goal-directed sedation to avoid accidental over-sedation, and improving adherence to the Trust's Wake Up and Breathe Protocol with particular focus on spontaneous awakening trials (SAT). Methods A QI team of two doctors and one pharmacist from the Critical Care Department was established. Baseline data were collected once weekly through March 2021, including all sedated patients across the Trust's two intensive care units (ICUs;housing 46 beds in total). Data included sedative agents and infusion rates, appropriateness for and implementation of SAT, documentation of a sedation plan, and recorded Richmond Agitation and Sedation Scale (RASS) score. Freetext answers from bedside staff helped identify barriers to change such as diluted skill mix, staffing pressures, lack of confidence and fear of adverse events. Baseline data were presented at a departmental QI meeting;feedback was gathered and thereafter data collection was streamlined to 10 patients per week across both ICUs, performed for 16 further weeks. Plan-do-study-act (PDSA) cycles were implemented based on data collected and barriers identified, including questionnaires to the medical team, departmental presentations and teaching, posters, altering pre-printed prescription charts, discussions with the Nurse Education team, and engaging in the department's Rehabilitation Month initiative. Results Baseline data revealed that half of protocol-defined suitable patients received SATs, and the most frequent RASS score was -4 in patients without neuromuscular blockade. These data were presented at a departmental QI meeting and awareness of the project was raised. Subsequent data showed that our practice, supported by interventions, improved over the 16 weeks. The average percentage of suitable patients receiving SATs rose from 54% to 86%. Documentation of sedation plans increased from 65% to 95%, and mean RASS scores showed improvement from -3.7 to -3.3. There was a significant reduction in the use of double-strength morphine and midazolam among non-COVID-19 patients, and weight-adjusted infusion rates of propofol and alfentanil also decreased. Discussion By focusing on broad, multidisciplinary stakeholder engagement, the QI team were able to identify and target multiple barriers to improved practice. Sequential interventions across multiple areas facilitated safe improvement in our sedation practice and adherence to local and national guidelines, with no adverse events reported.
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Service or Program: Throughout COVID-19, complex therapeutics and medication protocols left clinicians overwhelmed by contradicting information leading to drug-related problems (DRPs) potentially leading to ineffective pharmacotherapy and drug-related morbidity and mortality. DRPs queries are time consuming, utilize different resources, and require skills and experience to provide accurate answers3. Quick answers are paramount in the Emergency Department (ED) especially during pandemic period. Clinical pharmacists (CP) can identify and resolve DRPs but are only available from 7AM-3PM in ED. We set up on-call CP service for ED DRPs calls during out-of-office hours.This study aimed to assess the capacity of the service to capture 100% of calls received and to measure the time taken to resolve DRP queries compared to international standard. Justification/Documentation: A dedicated ED CP on-call phone line until 10pm daily was arranged by Hamad General Hospital Pharmacy (Qatar).Data was documented on a logbook/Electronic Medical Records (EMR) and analysed using predefined parameters. Adaptability: Between March-September 2020, 133 DRPs calls were received and resolved by CP. 38% of these were related to drug interaction/safety, adverse drug reactions, dose-adjustments, drug-allergies, and drug in pregnancy.30% were related to medication administration, such as infusion rates, titration, and IV compatibility. Those questions were mostly received from nurses(Figure 1).Appropriate dose selection and appropriate indication represented 21% and 11% respectively (Figure 2). Caller's acceptance rate to responses provided by CP were 100%. Responses were documented in patients' EMR. The call duration extracted from phone-log showed an average time of 4.66 minutes/call which is below average standard of 15-30 minutes. Significance: Availability of clinical pharmacists to provide quick, acceptable responses to DRPs queries, is crucial given the complexity and diversity of ED patients. During COVID-19, on-call clinical pharmacy service has proven its capability to resolve DRPs and support clinical decision-making process in a relatively shorter time.