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Chemical and microbiological stability, anticoagulant efficacy and toxicity of 35 and 90 mM trisodium citrate solutions stored in plastic syringes
  1. Paola Milla1,
  2. Maria Luisa Viterbo2,
  3. Sabino Mosca3,
  4. Silvia Arpicco1
  1. 1Department of Drug Science and Technology, University of Turin, Turin, Italy
  2. 2Hospital Pharmacy, San Giovanni Bosco Hospital, Turin, Italy
  3. 3Department of Anesthesiology and Resuscitation, San Giovanni Bosco Hospital, Turin, Italy
  1. Correspondence to Dr Paola Milla, Department of Drug Science and Technology, University of Turin, Via P Giuria 9, 10125 Turin, Italy; paola.milla{at}unito.it

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.

  • INTENSIVE & CRITICAL CARE
  • LABORATORY / QUALITY CONTROL
  • STABILITY AND INCOMPATIBILITY

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