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Chemical and microbiological stability, anticoagulant efficacy and toxicity of 35 and 90?mM trisodium citrate solutions stored in plastic syringes.

ABSTRACT: Background:Trisodium citrate is an interesting alternative to heparin for the prevention of circuit clotting during extracorporeal procedures, but some protocols require non-commercially available citrate concentrations. Little published information is available about the stability of diluted citrate solutions. Objectives:To evaluate the long-term stability, efficacy and toxicity of 35?mM and 90?mM trisodium citrate solutions prepared by diluting a commercially available sterile solution, stored in plastic syringes and used as an anticoagulant during citrate bag changes in the coupled plasma filtration adsorption (CPFA) technique in the COMPACT-2 clinical trial. Methods:The chemical stability of trisodium citrate solutions was evaluated by high-performance liquid chromatography after 7, 14, 21 and 28?days of storage. Sterility tests were performed both immediately after preparation and after 28?days of storage. Results:After 28?days of storage, the concentration of trisodium citrate had not changed in comparison with day 1, and both solutions passed the sterility test. A preliminary test indicated that a 35?mM solution is insufficient to ensure an effective anticoagulant action on an extracorporeal circuit, but the 90?mM solution was successfully used for 7 CPFA treatments in 2 patients, without clinical signs of toxicity. Conclusions:Both the 35?mM and 90?mM solutions are chemically and microbiologically stable for 28?days when stored at room temperature in 50?mL syringes protected by light. The 90?mM solution is an effective and safe regional anticoagulant in the CPFA protocol. Trial registration number:NCT01639664.

SUBMITTER: Milla P

PROVIDER: S-EPMC6319411 | biostudies-literature | 2018 Oct

REPOSITORIES: biostudies-literature

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Chemical and microbiological stability, anticoagulant efficacy and toxicity of 35 and 90 mM trisodium citrate solutions stored in plastic syringes.

Milla Paola P Viterbo Maria Luisa ML Mosca Sabino S Arpicco Silvia S

European journal of hospital pharmacy : science and practice 20170113 e2

<h4>Background</h4>Trisodium citrate is an interesting alternative to heparin for the prevention of circuit clotting during extracorporeal procedures, but some protocols require non-commercially available citrate concentrations. Little published information is available about the stability of diluted citrate solutions.<h4>Objectives</h4>To evaluate the long-term stability, efficacy and toxicity of 35 mM and 90 mM trisodium citrate solutions prepared by diluting a commercially available sterile s ...[more]

PMID: 31157074

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Project description:BACKGROUND:Non-tunneled hemodialysis catheters are currently used for critically ill patients with acute kidney injury requiring extracorporeal renal replacement therapy. Strategies to prevent catheter dysfunction and infection with catheter locks remain controversial. METHODS:In a multicenter, randomized, controlled, double-blind trial, we compared two strategies for catheter locking of non-tunneled hemodialysis catheters, namely trisodium citrate at 4% (intervention group) versus unfractionated heparin (control group), in patients aged 18 years or older admitted to the intensive care unit and in whom a first non-tunneled hemodialysis catheter was to be inserted by the jugular or femoral vein. The primary endpoint was length of event-free survival of the first non-tunneled hemodialysis catheter. Secondary endpoints were: rate of fibrinolysis, incidence of catheter dysfunction and incidence of catheter-related bloodstream infection (CRBSI), all per 1000 catheter-days; number of hemorrhagic events requiring transfusion, length of stay in intensive care and in hospital; 28-day mortality. RESULTS:Overall, 396 randomized patients completed the trial: 199 in the citrate group and 197 in the heparin group. There was no significant difference in baseline characteristics between groups. The duration of event-free survival of the first non-tunneled hemodialysis catheter was not significantly different between groups: 7 days (IQR 3-10) in the citrate group and 5 days (IQR 3-11) in the heparin group (p = 0.51). Rates of catheter thrombosis, CRBSI, and adverse events were not statistically different between groups. CONCLUSIONS:In critically ill patients, there was no significant difference in the duration of event-free survival of the first non-tunneled hemodialysis catheter between trisodium citrate 4% and heparin as a locking solution. Catheter thrombosis, catheter-related infection, and adverse events were not statistically different between the two groups. Trial registration Registered with Clinicaltrials.gov under the number NCT01962116. Registered 14 October 2013.

Project description:In recent animal experiments with suspensions of radiolabeled TiO2 nanoparticles large and highly variable radioactivity fractions were retained in disposable plastic syringes. After unloading between 10% and up to 70% of the loaded dose were still present in the syringes. As a consequence the effectively delivered nanoparticle dose to the animals was frequently much smaller than the nominal dose of the nanoparticles loaded into the syringe. The high variability of this nanoparticle retention challenges the application of a precise, predefined dose and creates a major error source when normalizing organ and tissue contents to the dose loaded into the syringe, which is usually set as the applied dose. A control study was performed employing six commonly used syringe types with seven types of radiolabeled oxide and metallic nanoparticles. For this purpose the syringes were loaded with a given volume of nanoparticle suspension, the radioactivity was measured, the syringe was unloaded and the activity measurement was repeated with the empty syringe. The highest retention values were found when using TiO2 nanoparticle suspensions with Tuberkulin type syringes. In the worst case between 6.6% and 79.1% of the nanoparticles were retained in the syringe. When using the same nanoparticle suspension with an insulin-type syringe the retention was reduced to 1.4% to 20.6%. For amorphous silica nanoparticles the maximum observed retention was 8% and for Au nanoparticles it was 5.1%. Further data gathered from in vivo animal imaging studies show that nanoparticle retention in syringes also affects experiments with nanoparticles such as exosomes, polymersomes, and protein-based nanoparticles investigated for possible applications in nanomedicine. Since the retention is highly variable the effectively applied dose cannot be determined by applying a simple syringe retention factor. The present work shall alert to the problem and illustrate its possible magnitude and unpredictable variability. As mitigation strategy adequate checks with different syringe types are proposed in order to find out whether a given combination of syringe type and nanoparticle suspension is affected by nanoparticle retention and, if necessary, to select a different syringe type that minimizes retention.

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Chemical and microbiological stability, anticoagulant efficacy and toxicity of 35 and 90?mM trisodium citrate solutions stored in plastic syringes.

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Chemical and microbiological stability, anticoagulant efficacy and toxicity of 35 and 90 mM trisodium citrate solutions stored in plastic syringes.

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