Short- and long-term survival of children treated with ventricular assist devices in Spain, based on 15 years' experience.

OBJECTIVES: To describe the use of ventricular assist devices (VAD) in children in Spain and to identify variables related to survival. METHODS: This is an observational cohort study of all children younger than 18 years of age who underwent an initial implantation of a VAD at any of the 6 paediatric heart transplant centres from May 2006 to December 2020. Subjects were identified retrospectively from each hospital's database. RESULTS: Paracorporeal VADs were implanted in 118 children [pulsatile (63%), continuous (30.5%) or both types (5.9%)]. Small children (<0.7 m2 of body surface area) comprised the majority of this cohort (63.3%). Overall, 67% survived to VAD explantation, and 64.9% survived to hospital discharge. Non-central nervous system haemorrhage (39%) and stroke (38.1%) were the most common complications. Body weight <5 kg, congenital heart disease, pre-implantation bilirubin >34 µmol/l and bridge to decision strategy were associated with a higher mortality at hospital discharge and in the long-term. Interagency registry for mechanically assisted circulatory support (INTERMACS) status 1 and cardiac arrest prior to VAD implantation were related to long-term mortality, whereas pre-implantation renal replacement therapy and extracorporeal membrane oxygenation were not related to mortality. CONCLUSIONS: In Spain, 67% of the VAD-supported children have been bridged to heart transplantation or to recovery. Body weight lower than 5 kg, congenital heart disease diagnosis, cholestatic liver dysfunction, bridge to decision as VAD strategy, INTERMACS-1 status and cardiac arrest were pre-implantation variables related to mortality, whereas pre-implantation renal replacement therapy and extracorporeal membrane oxygenation were not.

Hemolysis and methemoglobinemia in a child with left ventricular assist Levitronix PediMag.

A 5-month-old male was treated with left ventricular assist device due to cardiac failure secondary to dilated cardiomyopathy. The patient developed acute severe intravascular hemolysis with methemoglobinemia and renal failure, related to a mechanical problem due to pump cylinder misalignment. Secondary severe methemoglobinemia has not been previously described in patients undergoing ventricular assist device. Early detection of the signs and symptoms of hemolysis is crucial to prevent further complications.

Complicaciones infecciosas en niños tratados con oxigenación por membrana extracorpórea / Infectious complications in paediatric patients treated with extracorporeal membrane oxygenation

INTRODUCCIÓN: El objetivo de este estudio es analizar la incidencia de infección en los niños tratados con ECMO, el tratamiento y su evolución. MÉTODOS: Se realizó un estudio retrospectivo basado en una base de datos prospectiva en el que se incluyeron los niños menores de 18 años asistidos con ECMO entre septiembre de 2006 y noviembre de 2015. Se recogieron las características de los pacientes, la ECMO, los cultivos y el tratamiento de la infección. RESULTADOS: Se estudiaron 100 pacientes de 11 meses de edad mediana. El diagnóstico fue de cardiopatía en 94 pacientes. Se sospechó una infección y se inició antibioterapia en 51 pacientes, aunque solo se confirmó microbiológicamente en 22. Las infecciones más frecuentes fueron la sepsis (49%), neumonía (35,3%) e infección urinaria (9,8%). No existieron diferencias en los parámetros hematológicos y reactantes de fase aguda entre los niños con infección y el resto. Los niños que fallecieron presentaron mayor incidencia, no estadísticamente significativa, de infección durante la ECMO (60,4%) que los supervivientes (40,3%) (p = 0,07). La duración de ingreso en la UCIP fue mayor, sin significación estadística, en los pacientes con infección que en el resto: 57 frente a 37 días (p = 0,067). CONCLUSIONES: La frecuencia de infección en niños con ECMO es elevada, pero menos de la mitad son confirmadas microbiológicamente, sin existir parámetros específicos de infección. No se ha encontrado relación estadísticamente significativa de la infección con la mortalidad y la duración de ingreso en la UCIP

INTRODUCTION: The aim of this study was to analyse the incidence, treatment and evolution of infections in children treated with ECMO. METHODS: A retrospective study based on a prospective database was performed. Children under the age of 18 years treated with ECMO from September 2006 to November 2015 were included. The patients' clinical characteristics were collected, together with ECMO technique, cultures and treatment of infection. RESULTS: One hundred patients with a median age of 11 months were analysed. Heart disease was diagnosed in 94 patients. An infection was suspected and antibiotic treatment was initiated in 51 patients, although only 22 of them were microbiologically confirmed. The most common infection was sepsis (49%), followed by pneumonia (35.3%) and urinary tract infection (9.8%). There were no differences in haematological parameters and acute phase reactants between children with infection and those without. Children who died had a higher incidence of infection during ECMO (60.4%) than the survivors (40.3%), but the difference did not reach statistical significance (P = .07). The duration of admission in the PICU was 57 days in patients with infection vs 37 days in patients without infection but the difference was not statistically significant (P = .067). CONCLUSIONS: Infection in children with ECMO is common. There are no specific infection parameters and less than half of the clinical infections are confirmed microbiologically. There was no statistically significant correlation between infection and mortality or duration of PICU stay

Infectious complications in paediatric patients treated with extracorporeal membrane oxygenation. / Complicaciones infecciosas en niños tratados con oxigenación por membrana extracorpórea.

INTRODUCTION: The aim of this study was to analyse the incidence, treatment and evolution of infections in children treated with ECMO. METHODS: A retrospective study based on a prospective database was performed. Children under the age of 18 years treated with ECMO from September 2006 to November 2015 were included. The patients' clinical characteristics were collected, together with ECMO technique, cultures and treatment of infection. RESULTS: One hundred patients with a median age of 11 months were analysed. Heart disease was diagnosed in 94 patients. An infection was suspected and antibiotic treatment was initiated in 51 patients, although only 22 of them were microbiologically confirmed. The most common infection was sepsis (49%), followed by pneumonia (35.3%) and urinary tract infection (9.8%). There were no differences in haematological parameters and acute phase reactants between children with infection and those without. Children who died had a higher incidence of infection during ECMO (60.4%) than the survivors (40.3%), but the difference did not reach statistical significance (P=.07). The duration of admission in the PICU was 57 days in patients with infection vs 37 days in patients without infection but the difference was not statistically significant (P=.067). CONCLUSIONS: Infection in children with ECMO is common. There are no specific infection parameters and less than half of the clinical infections are confirmed microbiologically. There was no statistically significant correlation between infection and mortality or duration of PICU stay.

Set of Quality Indicators of Pediatric Intensive Care in Spain: Delphi Method Selection.

INTRODUCTION: This study objective was to identify, select, and define a basic set of quality indicators for pediatric intensive care in Spain. METHODS: (1) Review of the literature to identify quality indicators and their defining elements and (2) selection of indicators by consensus of a group of experts using basic Delphi methodology (2 rounds) and forms distributed by email among experts from the Spanish society of pediatric intensive care. RESULTS: We selected quality indicators according to their relevance and feasibility and the experts' agreement on their incorporation in the final set. We included only those indicators whose assessment was within the highest tertile and greater than or equal to 70% evaluator agreement in the final selection. Starting from an initially proposed set of 136 indicators, 31 experts first selected 43 indicators for inclusion in the second round. Twenty indicators were selected for the final set. This "top 20" set comprised 9 process indicators, 9 of results (especially treatment-associated adverse effects), and 2 indicators of structure. Several of them are classical indicators in intensive care medicine (rates of hospital-acquired infections, pressure ulcers, etc.), whereas others are specifically pediatric (eg, unrestricted parent visitation or training the parents of technology-dependent children). CONCLUSIONS: We reached a consensus on a set of 20 essential quality indicators for pediatric intensive care in Spain. A significant subset reflects the peculiarities of pediatric care. We consider this subset as a starting point for future projects of network collaboration between pediatric intensive care units in Spain.

Implementation of smart pump technology in a paediatric intensive care unit.

Patient safety is a matter of major concern that involves every health professional. Nowadays, emerging technologies such as smart pumps can diminish medication errors as well as standardise and improve clinical practice with the subsequent benefits for patients. The aim of this paper was to describe the smart pump implementation process in a paediatric intensive care unit (PICU) and to present the most relevant infusion-related programming errors that were prevented. This was a comparative study between CareFusion Alaris Guardrails(®) and Hospira MedNet(®) systems, as well as a prospective and intervention study with analytical components carried out in the PICU of Gregorio Marañón General and Teaching Hospital. All intravenous infusions programmed with a pump in the eleven beds of the unit were analyzed. A drug library was developed and subsequently loaded into CareFusion and Hospira pumps that were used during a three month period each. The most suitable system for implementation was selected according to their differences in features and users' acceptance. Data stored in the pumps were analyzed to assess user compliance with the technology, health care setting and type of errors intercepted. The implementation process was carried out with CareFusion systems. Compliance with the technology was 92% and user acceptance was high. Vacation substitution and drug administration periods were significantly associated with a greater number of infusion-related programming errors. High risk drugs were involved in 48% of intercepted errors. Based on these results we can conclude that implementation of smart pumps proved effective in intercepting infusion-related programming errors from reaching patients. User awareness of the importance of programming infusions with the drug library is the key to succeed in the implementation process.

Risks in the implementation and use of smart pumps in a pediatric intensive care unit: application of the failure mode and effects analysis.

OBJECTIVES: The aim of this study was to identify risk points in the different stages of the smart infusion pump implementation process to prioritize improvement measures. METHODS: Failure modes and effects analysis (FMEA) in the pediatric intensive care unit (PICU) of a General and Teaching Hospital. A multidisciplinary team was comprised of two intensive care pediatricians, two clinical pharmacists and the PICU nurse manager. FMEA was carried out before implementing CareFusion infusion smart pumps and eighteen months after to identify risk points during three different stages of the implementation process: creating a drug library; using the technology during clinical practice and analyzing the data stored using Guardrails® CQI v4.1 Event Reporter software. RESULTS: Several actions for improvement were taken. These included carrying out periodical reviews of the drug library, developing support documents, and including a training profile in the system so that alarms set off by real programming errors could be distinguished from those caused by incorrect use of the system. Eighteen months after the implementation, these measures had helped to reduce the likelihood of each risk point occurring and increase the likelihood of their detection. CONCLUSIONS: Carrying out an FMEA made it possible to detect risk points in the use of smart pumps, take action to improve the tool, and adapt it to the PICU. Providing user training and support tools and continuously monitoring results helped to improve the usefulness of the drug library, increased users' compliance with the drug library, and decreased the number of unnecessary alarms.

Preparation of intravenous drug administration guidelines for a pediatric intensive care unit.

Drug administration is one of the main sources of errors in pediatric intensive care units (PICUs). An available guide for intravenous drug administration might be useful. The aim of this article is to present the methodology and results for the development of a guide for intravenous drug administration in a PICU. A total of 116 drugs were included. Standard concentrations, diluents, technique for reconstitution and dilution, stability, rate of administration, and relevant observations were defined for each drug according to a review of the most commonly used literature resources. The main unique feature of this article is that it includes standard concentrations for each drug.

Prevention and treatment of intraluminal catheter thrombosis in children hospitalised in a paediatric intensive care unit.

AIM: The aim of the study was to develop and implement a protocol for the prevention and treatment of catheter related intraluminal thrombosis in a paediatric intensive care unit METHODS: A computerised search was carried out on MEDLINE, through PubMed, using the medical subject heading 'central venous catheter', 'central venous access device', 'central venous line' associated with 'occlusion', 'obstruction', 'catheter-related thrombosis', 'critically ill patients' and 'thrombolytic therapy'. References of reviewed articles were also searched for relevant titles as well as non-randomised controlled trials and series of cases when no information of higher level of evidence was available. RESULTS: With the information gathered, a protocol for the prevention and treatment of catheter related intraluminal thrombosis was elaborated and those recommendations that best suit our environment were included. They were agreed upon by a broad panel of professionals working in the Pediatric Intensive Care Unit and the Pharmacy Department. CONCLUSIONS: Due to the variety of options available for the pharmacotherapeutic management of intraluminal catheter thrombosis, one measure to improve the quality of the therapy and to diminish the variability in the prescription could be the implementation of a protocol as described in this paper.

Implementing smart pump technology in a pediatric intensive care unit: a cost-effective approach.

OBJECTIVE: To analyze the cost effectiveness of implementing smart infusion pump technology in a pediatric intensive care unit (PICU). MATERIAL AND METHODS: An observational, prospective, intervention study with analytical components was carried out. A drug library was developed and integrated into the Carefusion Alaris Guardrails® infusion systems. A systematic analysis of all the data stored on the devices during use was performed by the data processing program Guardrails® CQI v4.1 Event Reporter. Intercepted errors were classified in terms of their potential severity and probability of causing an adverse effect (PAE) had they reached the patient. Knowing the estimated cost of a preventable adverse effect (AE), we analyzed costs saved and the profit/cost ratio resulting from the implementation process. RESULTS: Compliance with the drug library was 92% and during the study period 92 infusion-related programming errors were intercepted, leading to a saving of 172,279 euros by preventing AEs. This means that 2.15 euros would be obtained for each euro invested in hiring a pharmacist to implement this technology. DISCUSSION: The high percentage of use of safety software in our study compared to others allowed for the interception of 92 errors. The estimation of the potential impact of these errors is based on clinical judgment. The cost saved might be underestimated because the cost of an AE is usually higher in pediatrics, indirect and intangible costs were not considered and pharmacists involved do not spend the whole day on this task. CONCLUSIONS: Smart pumps have shown to be profitable in a PICU because they have the ability to intercept potentially serious medication errors and reduce costs associated with such errors.

Impact of implementing smart infusion pumps in a pediatric intensive care unit.

PURPOSE: The impact of smart infusion pumps on the interception of errors in the programming of i.v. drug administrations on a pediatric intensive care unit (PICU) is investigated. METHODS: A prospective observational intervention study was conducted in the PICU of a hospital in Madrid, Spain, to estimate the patient safety benefits resulting from the implementation of smart pump technology (Alaris System, CareFusion, San Diego, CA). A systematic analysis of data stored by the devices during the designated study period (January 2010-June 2011) was conducted using the system software (Guardrails CQI Event Reporter, CareFusion). The severity of intercepted errors was independently classified by a group of four clinical pharmacists and a group of four intensive care pediatricians; analyses of intragroup and intergroup agreement in perceptions of severity were performed. RESULTS: During the 17-month study period, the overall rate of user compliance with the safety software was 78%. The use of smart pump technology resulted in the interception of 92 programming errors, 84% of which involved analgesics, antiinfectives, inotropes, and sedatives. About 97% of the errors resulted from user programming of doses or infusion rates above the hard limits defined in the smart pump drug library. The potential consequences of the intercepted errors were considered to be of moderate, serious, or catastrophic severity in 49% of cases. CONCLUSION: The use of smart pumps in a PICU improved patient safety by enabling the interception of infusion programming errors that posed the potential for severe injury to pediatric patients.

Rare presentation of shock and acute mesenteric ischaemia secondary to acute adrenal insufficiency in an 11-year-old male.

An 11-year-old Caucasian male with history of abdominal pain, diarrhoea, fatigue, emesis and fever on the previous days presented with dehydratation, shock and acute mesenteric ischaemia. Final diagnosis of Addison's disease was made.

Development of a compatibility chart for intravenous Y-site drug administration in a pediatric intensive care unit.

Pediatric patients admitted to intensive care units are likely candidates for intravenous drug administration. These patients may sometimes have limited vascular access, so availability of compatibility charts for intravenous Y-site administration may help daily clinical practice. A 2-dimensional table with the 47 intravenous drugs more commonly administered in the authors' pediatric intensive care unit was drawn up based on a review of 4 databases routinely used for checking drug compatibilities. The level of concordance between the various sources used for the review was strong (κ>0.8). However, an awareness of the limitations of each of these databases will help to optimize search results.

Developing a drug library for smart pumps in a pediatric intensive care unit.

BACKGROUND: The most serious medication errors occur during intravenous administration. The potential consequences are more serious the more critical and younger the patient. Smart pumps can help to prevent infusion-related programming errors, thanks to associated dose-limiting software known as "drug library". Drug libraries alert the user if pre-determined high dosage limits are exceeded or if entry is below pre-determined low dosage limits. OBJECTIVE: To describe the process for developing a specific drug library for a pediatric intensive care unit (PICU) and the key factors for preventing programming errors. METHODS AND MATERIALS: The study was performed by a multidisciplinary team consisting of a clinical pharmacist, a PICU pediatrician, and the chief nurse of the unit. The process of developing the drug library lasted seven months. A literature review was carried out to determine standard concentrations and accurate limits for intravenous administration of high-risk drugs. Alaris(®) syringe pumps and Guardrails(®) CQI v4.1 Event Reporter software were used. RESULTS: Several manufacturers offer smart pump technology. Users should be aware of differences in features, such as definition of parameters and associations between them, definition of safety limits, organization of the drug library, and data use. Our infusion pump technology covered 108 drugs. Compliance with the drug library was 85% and nurses' acceptance of the drug library was high as 94% would recommend implementation of this technology in other units. After nine months of implementation, several potentially harmful infusion-related programming errors were intercepted. CONCLUSIONS: Drug libraries are specifically designed for a particular hospital unit, and may condition the success in implementing this technology. Implementation of smart pumps proved effective in intercepting infusion-related programming errors after nine months of implementation in a PICU.

Smart pump alerts: all that glitters is not gold.

INTRODUCTION: The implementation of smart pump technology can reduce the incidence of errors in the administration of intravenous drugs. This approach involves developing drug libraries for specific units and setting hard and soft limits for each drug. If a programming error occurs and these limits are exceeded, an alarm sounds and the infusion can be blocked. A detailed analysis of these alarms is essential in order not to bias the results in favor of a positive impact of this technology. PURPOSE: To evaluate the results of the first analysis of the use of smart infusion pumps and to assess the significance and practical implications of the alarms sounded. METHODS: The study was performed by a multidisciplinary team that consisted of a clinical pharmacist, a pediatrician from the pediatric intensive care unit (PICU), and the chief nurse of the unit. A library of 108 drugs was developed over a 7-month period and introduced into 40 syringe pumps and 12 volumetric pumps (Alaris(®) with Plus software) before being applied in 6 of the 11 beds in the PICU. After four month's use, data were analyzed using the Guardrails(®) CQI v4.1 Event Reporter program. RESULTS: Following the first four months of implementation, compliance with the drug library was 87%. By analyzing the alerts triggered, we were able to detect problems such as the need to increase user training, readjust limits that did not correspond to clinical practice, correct errors in the editing of the drug library and including a training profile. CONCLUSION: It is difficult to obtain accurate data on the true impact of this technology in the early stages of its implementation. This preliminary analysis allowed us to identify improvement measures to distinguish, in future evaluations, the alarms triggered by a real programming error from those caused by incorrect use.

Treatment of monomorphic B-cell lymphoma with rituximab after liver transplantation in a child.

Rituximab, a monoclonal antibody directed against the B-cell specific CD20 antigen has been used with success in post-transplant lymphoproliferative disorder (PTLD) of B-cell phenotype. However, the use of such drug in children with liver transplantation and PTLD is very limited. We report a 2-yr-old liver transplant recipient with monomorphic non-Hodgkin lymphoma of B-cell origin. The lymphoma did not respond to immunosuppression withdrawal, with a subsequent allograft rejection. Despite resumption of immunosuppression and rejection treatment, the lymphoma was successfully treated with rituximab.