Can we use normal saline stored under stress conditions? A simulated prehospital emergency medical setting.

Background: Data on stability and suitability to use normal saline stored under stress conditions in ambulances is lacking. Objective: We aimed to study the impact of exposure to extreme temperature variations on normal saline stability and compatibility with its packaging. Methods: Normal saline in 96 polyolefin bags were exposed to continuous temperature of 22, 50, and 70 °C or to a cyclic temperature of 70 °C per 8 h and 22 °C per 16 h. The bags were sampled at 12, 24, 48 and 72 h and at 1, 2, 3, and 4 weeks in the short- and long-term experiments, respectively. Solution inside the bags was evaluated for any evidence of crystallization, discoloration, turbidity, or pH changes. A sample of normal saline was withdrawn from each bag to analyze sodium and chloride levels. Results: Precipitation, discoloration, or turbidity were not observed in the solution inside normal saline bags. The average pH was 5.59 at 22 °C, 5.73 at 50 °C, 5.86 at 70 °C and 5.79 at cyclic exposure. In the short- and long-term experiments, sodium and chloride concentrations were within 100.2-111.27% and 99.04-110.95%, respectively. Leaching of the plastic components in the polyolefin bag into the normal saline solution was not detected. Conclusions: Sodium and chloride levels of normal saline were stable and compatible with polyolefin bags stored in simulated continuous and cyclic extreme temperatures for around one month. The effect of storage in the cabinet of operational ambulance vehicles during different seasons in arid countries is yet to be evaluated in real-world conditions, to further confirm our results.

Normal saline: Past, present, and future.

Normal saline (NS) is the most widely used agent in the medical field. However, from its origin to its widespread application, it remains a mystery. Moreover, there is an ongoing debate on whether its existence is reasonable, harmful to the human body, or will still exist in the future. The current review traces back to the origins of NS and provides a brief overview of the current situation of infusion. The purpose may shed some light on the possibility of the existence of NS in the future by elaborating on the origin of NS and the research status of the impact of NS on the human body.

Changing practice to using pre-filled syringes for flushing IV cannulas.

In the UK, the Medicines and Healthcare products Regulatory Agency classifies 'pre-filled syringes' for flushing Intravenous (IV) cannulas and IV access devices as 'borderline' devices and offers some advice on how control measures can help mitigate risks. The Medicines Act (1968) and Medical Device Regulations try to address the legal position of these devices and allow each employer to identify those groups of staff allowed to use them. In turn, this may help address anomalies around the need to prescribe and document their use. This article describes how one large university health board in Wales implemented a change in products and practice and explores the issues around adopting and using CE-marked pre-filled, sterile syringes of 0.9% sodium chloride in place of manually drawing up an IV flush (the CE mark indicates devices that conforms with European legal requirements). Whether the use of individual components or a single pre-filled device can lead to a streamlined and cost-effective way to manage the flushing of IV cannula and vascular access devices was explored. Additional risk factors were identified, and the legal status clarified in line with current guidelines and regulations. As 0.9% sodium chloride in ampoules and vials is classified as a prescription-only medicine, the administration needs control via formal prescription or a patient group direction. Adopting and using these pre-filled syringes as CE-marked medical devices requires careful consideration and sign-off from each employing authority, before implementing them for flushing IV cannulas and IV access devices.

Physical Compatibility and Chemical Stability of Fentanyl and Naloxone Hydrochloride in 0.9% Sodium Chloride Injection Solution for Patient-Controlled Analgesia Administration.

BACKGROUND AND OBJECTIVE: The combination of naloxone hydrochloride (NH) and fentanyl citrate (FC) in patient-controlled analgesia (PCA) is examined to reduce the risk of opioid-induced nausea and vomiting. However, there are no such commercially available drug mixtures, and there is also no published evidence on the compatibility and stability of NH and FC. Thus, the primary purpose of the current research is to investigate the physical compatibility and chemical stability of NH when mixed with FC over a 72-h period in a 0.9% sodium chloride injection solution for PCA administration under storage at 4°C and 25°C. METHODS: Test solutions of 20 µg/mL FC and 4 µg/mL NH were prepared and stored in polyvinyl chloride (PVC) bags or glass bottles with a 0.9% sodium chloride injection solution as the diluent. During the 72-h storage period at 4°C or 25°C without light protection, the concentrations of the test drugs were assayed via high-performance liquid chromatography (HPLC), and the physical compatibility was determined with the naked eye. Furthermore, pH measurement of each sample was also performed with a pH meter. RESULTS: The percentages of the initial concentrations of FC and NH in the various solutions were maintained at a minimum of 98% over the 72-h study period. All of the mixtures remained clear and colourless throughout the observation period, and no precipitation or turbidity was observed in any of the batches. CONCLUSION: The 20 µg/mL FC test solution was physically compatible and chemically stable with the 4 µg/mL NH test solution when stored at 4°C or 25°C in PVC bags or glass bottles containing the 0.9% sodium chloride injection solution.

Heparinized Saline Solution vs. Saline Solution (0.9% Sodium Chloride) for the Maintenance of Dorsal Pedal Arterial Catheter Patency in Dogs Undergoing General Anesthesia: A Pilot Study.

Heparin is widely used as an anticoagulant solution for maintaining arterial catheter patency. In humans, increasing evidence suggests that heparinized saline solution (HS) has no advantages over a saline (0.9% sodium chloride) solution (SS) in maintaining arterial catheter patency. To date, no studies have been conducted on the effectiveness of these solutions at maintaining arterial catheter patency in veterinary medicine. The objective of this pilot study was to determine the feasibility of a study and to report the treatment efficacy comparing HS and SS for the maintenance of the dorsal pedal arterial catheter patency during direct arterial blood pressure measurements in anesthetized dogs. Client-owned dogs undergoing abdominal surgery were allocated to two groups to receive either a continuous infusion of HS or SS through the dorsal pedal artery, and the arterial pressure waveform was monitored during general anesthesia. Our feasibility outcomes included the proportion of the screened veterinary patients that completed the study and the success rate of arterial catheter placement. The clinical outcomes were assessed by the number of catheter-flushing procedures, occlusion rate, the duration of the initial catheter-flushing procedures, and the duration of catheter occlusion. Of the 51 dogs screened, 41 (80.4%) completed the study. The success rate of arterial catheter placement in the HS and SS groups were 87.5 and 80.0%, respectively. There were no differences in the number of catheter-flushing procedures and occlusion rate between groups (28.6 vs. 20.0%, relative risk [RR]: 1.429, 95% confidence interval [CI]: 0.472-4.323, P = 0.719 and 14.3 vs. 15.0%, RR: 0.952, 95% CI: 0.217-4.179, P = 1.000, respectively). No differences were found in the probability of time to the initial catheter-flushing procedure and occlusion between groups assessed by the Kaplan-Meier method (P = 0.546 and P = 0.867, respectively). This study revealed the feasibility of a study comparing HS and SS for dorsal pedal arterial catheter patency during direct arterial blood pressure measurements in anesthetized dogs. Clinical outcome analyses were underpowered and thus, could not determine the meaningful differences in treatment efficacy between the groups. However, the information gained from this study provides insight for future study designs.

Catheter lock solutions to prevent CVAD-related infection.

Demand for vascular access devices to meet the clinical needs of patients has increased dramatically in recent years, with a disproportionate increase in the numbers of individuals requiring a central venous access device (CVAD). With this increasing number of patients becoming recipients of CVADs globally each year, the associated incidence of catheter-related bloodstream infections (CRBSIs) is also increasing. In addition, there is strong evidence to demonstrate that antimicrobial resistance is a global challenge. There is a need to change the approach to CVAD management and get back to basics through a clearer understanding of how the incidence of CRBSIs can be reduced. This includes the role of biofilm and how its development can be inhibited through the use of an effective lock solution, and the avoidance of antibiotics.

Clinical study of two kinds of different invasive arterial blood pressure flushing liquid / 中国实用护理杂志

Objective To discuss the clinical effect of normal saline flushing and heparinized saline flushing in invasive arterial blood pressure monitoring in the critical patients. Methods A total of 140 critical patients were randomly divided into the experimental group and the control group with 70 cases in each group according to the envelope method. The experimental group used normal saline for tube flushing, the control group used heparinized saline (5 U/ml) for tube flushing. The incidence of complications and coagulation index were compared between two groups. Results There was no statistically difference in the incidence of the catheter jam and local infection (P>0.05). The incidence of bleeding events was 14.3% (10/70) in the control group, which was higher than 2.9% (2/70) of the experimental group. The difference was statistically significant(χ2=4.466, P<0.05). The activated partial thromboplastin time, prothrombin time of the control group were (32.22 ± 4.22) s, (11.56 ± 2.12) s, which were longer than (29.84 ± 3.64) s, (10.66 ± 1.48) s of the experimental group. And international normalized ratio of the control group was 1.12±0.14, which was higher than 1.03±0.20 of the experimental group. The difference was statistically significant (t values were-3.573,-2.912,-3.084, P <0.05). Conclusions The normal saline flushing liquid was more safer and reliable in the invasive arterial blood pressure monitoring.

Bipolar versus monopolar resection of benign prostate hyperplasia: a comparison of plasma electrolytes, hemoglobin and TUR syndrome.

BACKGROUND: Bipolar and monopolar transurethral resection of prostate (TURP) are both widely used for surgical treatment of benign prostatic hyperplasia. Systemic absorption of irrigation fluids during TURP operations leads to variations in blood chemistry. The aim of this prospective clinical study was to compare two different surgical techniques and the systemic effects of irrigation solutions (5 % mannitol vs. 0.9 % sodium chloride) under standardized anesthesia care. METHODS: Fifty-two patients who were scheduled for elective TURP were enrolled in the study. Patients were divided into two groups; the group M; 5 % mannitol was used for irrigation and the group B; 0.9 % sodium chloride was used for irrigation. Spinal anesthesia was performed to all patients. The patients' demographics, prostate volumes, hemodynamic parameters, volumes of irrigation, and IV fluids were recorded. Serum electrolytes (Na+, K+) and hemoglobin (Hb) were analyzed in blood samples taken before the operation (control), at the 45th min of the operation (1st measurement), and 1 h after the end of the surgery (2nd measurement) and recorded. RESULTS: The Na+ value of group M was significantly lower in both the 1st and 2nd measurements compared with the control value (p < 0.001 and p < 0.001). Na+ values of group M were also significantly lower than group B in both the 1st and 2nd measurements (p < 0.001 and p < 0.001). The change in Na+ levels was found to be statistically significant (p < 0.001) in group M, whereas the intergroup changes were not statistically significant in group B. CONCLUSION: Our results demonstrated that bipolar resection coupled with 0.9 % sodium chloride has minimal effects on serum sodium levels compared with monopolar resection. Clinicaltrials.gov identifier NCT02681471.

Varied flushing frequency and volume to prevent peripheral intravenous catheter failure: a pilot, factorial randomised controlled trial in adult medical-surgical hospital patients.

BACKGROUND: Research has identified high failure rates of peripheral intravenous catheter (PIVC) and varied flushing practices. METHODS: This is a single-centre, pilot, non-masked, factorial randomised controlled trial. Participants were adults, with a PIVC of expected use ≥24 hours (n = 160), admitted to general medical or surgical wards of a tertiary referral hospital in Queensland (Australia). Patients were randomly allocated to one of four flush groups using manually prepared syringes and 0.9 % sodium chloride: 10 mL or 3 mL flush, every 24 or 6 hours. The primary endpoint was PIVC failure, a composite measure of occlusion, infiltration, accidental dislodgement and phlebitis. RESULTS: PIVC average dwell was 3.1 days. PIVC failure rates per 1000 hours were not significantly different for the volume intervention (4.84 [3 mL] versus 7.44 [10 mL], p = 0.06, log-rank). PIVC failure rates per 1000 hours were also not significantly different for the frequency intervention (5.06 [24 hour] versus 7.34 [6 hour], p = 0.05, log-rank). Cox proportional hazard regression found neither the flushing nor frequency intervention, or their interaction (p = 0.21) to be significantly associated with PIVC failure. However, female gender (hazard ratio [HR] 2.2 [1.3-3.6], p < 0.01), insertion in hand/posterior wrist (HR 1.7 [1.0-2.7], p < 0.05) and the rate per day of PIVC access (combined flushes and medication pushes) (HR 1.2 [1.1-1.4], p < 0.01) significantly predicted PIVC failure. CONCLUSION: Neither increased flushing volume nor frequency significantly altered the risk of PIVC failure. Female gender, hand/posterior wrist placement and episodes of access (flushes and medication) may be more important. Larger, definitive trials are feasible and required. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry: ACTRN12615000025538 . Registered on 19 January 2015.

Stability Analysis of Levofloxacin Hydrochloride and Carbazochrome Sodium Sulfonate in 0.9% Sodium Chloride Injection / 中国药房

OBJECTIVE:To explore the stability of levofloxacin hydrochloride and carbazochrome sodium sulfonate in 0.9%So-dium chloride injection,and provide reference for their compatible use in clinic. METHODS:HPLC was performed on the column of Phenomenex Gemini C18 with mobile phase A of acetonitrile and B of 0.01 mol/L Ammonium biphosphate solution(adjusted to pH 3.0 with phosphoric acid)(gradient elution)at a flow rate of 1.0 ml/min,the detection wavelength was 295 nm for levofloxa-cin hydrochloride and 364 nm for carbazochrome sodium sulfonate,temperature was 30 ℃,and the injection volume was 20 μl. The changes of contents,appearance and pH value of the solution in the mixture were investigated. RESULTS:The linear range was 7.03-80.06 μg/mL for levofloxacin hydrochloride(r=0.9995)and 1.70-34.04 μg/mL for carbazochrome sodium sulfonate(r=0.9998);RSDs of precision and reproducibility tests were no more than 2.0%;recoveries were 98.75%-100.63%and 98.00%-100.83%, and RSDs were 0.65% and 0.99%(n=9),respectively. In normal temperature,the contents of levofloxacin hydrochloride and car-bazochrome sodium sulfonate after mixing with 0.9% Sodium chloride injection within 6 h showed no significant decrease,and the appearance and pH value showed no obvious changes. CONCLUSIONS:The mixing of levofloxacin hydrochloride and carbazo-chrome sodium sulfonate with 0.9% Sodium chloride injection in room temperature is stable within 6 h,they can compatibly use synergistically in clinic.

Compatibility Stability of Muscular Amino Acids and Peptides and Nucleosides for Injection in Different In-fusions / 中国药师

Objective:To investigate the compatibility stability of muscular amino acids and peptides and nucleosides for injection in different infusions to provide basis for clinical application .Methods: The compatibility stability of muscular amino acids and pep-tides and nucleosides for injection respectively in 0.9%sodium chloride injection , 5% glucose injection , 10%glucose injection and glucose and sodium chloride injection was studied , and the indices included the appearance , pH value , number of insoluble particles and contents of hypoxanthine and polypeptides .Results:All the solutions were transparent .The pH value and the contents of hypoxan-thine and polypeptides showed no significant changes .When muscular amino acids and peptides and nucleosides for injection was mixed with 10%glucose injection , the number of insoluble particles (≥10 μm) was the smallest , which met the requirement in Chi-nese pharmacopoeia (2015 edition,volume Ⅳ).When it was mixed with 0.9% sodium chloride injection, 5% glucose injection and glucose and sodium chloride injection , the number of insoluble particles (≥10 μm) was beyond the limits .The number of insoluble particles (≥25 μm) in all the solutions met the requirement .Conclusion: The most suitable solvent for muscular amino acids and peptides and nucleosides for injection is 10%glucose injection .

[Is physiological saline really physiological? Hyponatreamia treatment--small deviations from the rules of appropriate therapy create serious complications and side effects]. / Czy sól fizjologiczna jest fizjologiczna? Leczenie hiponatremii--male odstepstwa od regul prawidlowego leczenia powoduja powazne powiklania i objawy uboczne.

Physiological saline can hardly be treated as physiological as it contains qualitatively and quantitatively different amounts of electrolytes. In particular, it contains 50% more chlorine ions than serum. Physiological saline can cause metabolic acidosis and in diabetic patients hyperchloremic acidosis. In comparison with Ringer solution and plasma-lyte, physiological saline is causing higher number of untoward effects and mortality associated with surgery. Ringer solution should be used in the situations requiring expansion of extracellular fluid. Physiological saline is a solution of choice in hypochloremic alkalosis in the case of brain injuries quite unfavourable is unnecessary rapid correction with physiological saline which can lead to serious sequelae in form of brain oedema and central extrapontine myelinolysis (osmotic demyelinisation) and permanent brain lesions. The hyponatremia's treatment depends on severity of symptoms, neurological deficit motivates immediate 4-6 mmol/l infusion, but further correction should be prolonged to 24-hrs; cautious correction corresponds to 8-mmol/l for 24 hrs. The modern treatment encompasses the introduction of vasopressin receptors antagonist--vaptans.

Management of central venous catheters in pediatric onco-hematology using 0.9% sodium chloride and positive-pressure-valve needleless connector.

PURPOSE: To describe, in a sample of pediatric onco-hematological patients, the rate of occlusions in unused central venous catheters (CVC) flushed once a week with a 0.9% sodium chloride solution through a positive-pressure-valve needleless connector. METHOD: Retrospective cohort study. Subjects aged 0-17 years were identified through a manual search in medical and nursing records and were observed for two years or until the occurrence of one of the following events: start or resume of continuous infusion; CVC removal; death. The primary study outcome was the frequency of CVC occlusion (partial or complete). RESULTS: Fifty-one patients were identified (median age 6 years). The median duration of follow-up was 169 days (IQR 111-305). During the follow up period, 14 patients (27%) had one CVC occlusion, in 2 cases (4%) the occlusion was complete, in 12 (23%) partial. All the occlusions were solved without the need for catheter removal. The lumen diameter ≤ 4.2 vs > 4.2 French showed a statistically significant association with occlusion at multivariate analysis (OR 4.0; 95% CI 1.1-14.7). CONCLUSIONS: Our findings are reassuring with respect to the management of the CVC using the adopted protocol. The study provides useful information for patient care, by verifying the performance of the adopted CVC management protocol and by identifying critical areas for nursing care.

Stability-Indicating UPLC Method for Tramadol HCl Impurities in the Tramadol Injection after Dilution by Infusion Fluids (5% Dextrose and 0.9% Sodium Chloride).

A novel, rapid, and sensitive ultra-performance liquid chromatography (UPLC) method has been developed and validated as per ICH guidelines for the determination of tramadol HCl impurities in the tramadol HCl injection after reconstitution by infusion fluids (5% dextrose and 0.9% sodium chloride). The tramadol HCl injection is for the treatment of patients with moderate-to-severe pain. The stability of the reconstituted solution is critical before intravenous injection. The literature search resulted in few published articles on assays of tramadol in infusion fluids by conventional HPLC. No attempts have yet been made to determine the impurities in infusion fluids, as the concentration of tramadol after reconstitution is extremely low (0.4 mg/mL) and that of impurities is even lower. The proposed method is novel as it allows the quantitation of the impurities of tramadol HCl and is based on modern chromatographic techniques like UPLC. The method was developed using the Waters Acquity BEH C18 column with a mobile phase consisting of a gradient mixture of solvent A (trifluroacetic acid buffer) and solvent B (methanol: acetonitrile). The model stability study was designed by diluting the tramadol HCl injection in the 5% dextrose injection and 0.9% sodium chloride injection. Each mixture was kept under storage at room temperature (25 ± 2°C) for testing at initial, 2, 4, 8, 12, 18 & 24 hours. The validation study illustrates that the proposed method is suitable for the determination of tramadol and its impurities. The proposed method makes use of the LC-MS-compatible mobile phase. It can be useful for the determination of tramadol HCl and its impurities in plasma samples and other pharmaceutical dosage forms.

Chemical Stability of Disposable Infusion Bag of Total Parenteral Nutrition / 中国药房

OBJECTIVE:To study the chemical stability of disposable infusion bag of total parenteral nutrition.METHODS:0.9% sodium chloride injection was infused into the disposable infusion bag of total parenteral nutrition and set at 8 ℃ or 37 ℃ for different duration(0,24,48,and 72 h) as sample solution.The sample solution was compared with blank control(0.9% sodium chloride injection contained in glass bottle) in respect of pH value,metal ion,indissoluble particle,chloride,reduction substance,UV absorbance and dissolution of cyclohexanone.RESULTS:Each index was stable when sample solution was set at 8 ℃ for 24 h.Reduction substance and dissolution of cyclohexanone increased when solution was set at 37 ℃ with time prolonged,as compared with blank control.At 37℃ UV absorbance is more than that at 8 ℃.CONCLUSION:It is suitable to set disposable infusion bag of total parenteral nutrition at 8 ℃ after infusing with injection and use up within 24 h.