drugset / Trial / NCT03630224

Plasmalyte Versus Saline in Trauma Patients

NCT03630224

Phase 3 Terminated 365 enrolled Assistance Publique - Hôpitaux de Paris
RandomizedParallel-groupDouble-blindTreatment

Summary

Fluid resuscitation remains the cornerstone for the care of severe trauma patients to compensate for blood loss, to compensate for capillary leak induced by systemic inflammation but also to prevent the detrimental consequences of traumatic rhabdomyolysis. Isotonic saline (NaCl 0.9%), called "physiological serum" is the standard fluid for the resuscitation of severely injured patients. However, the formulation of NaCl 0.9% is not really physiological since its chloride concentration is 1.5 higher than the one of human plasma. This excessive chloride concentration leads to hyperchloremic acidosis and to a drop in renal perfusion after isotonic saline infusion. For this reason, we wonder whether fluid resuscitation with Plasmalyte would be beneficial for renal function of trauma patients in comparison with NaCl 0.9%. Our research question is: In a population of trauma patients at high risk of acute kidney injury, does a fluid resuscitation with Plasmalyte Viaflo lower the incidence of severe acute kidney injury (stage 2 or 3 according to the KDIGO classification) compared with a resuscitation with isotonic saline (NaCl 0.9%)?

Timeline

Start
2019-06-24
Primary completion
2023-08-18
Completion
2023-08-18

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Plasmalyte Other / unclassified 20000 ml
Comparator sodium chloride Unknown 20000 ml

Indications