Plasmalyte Versus Saline in Trauma Patients

• Status: Recruiting
• Trial end date: 2022-06-24
• Target enrollment: 0
• Participant gender: All

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%)?

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Plasma-lyte 148

Criteria

Inclusion Criteria:

• Severe trauma defined by at least one Vittel criteria

• Prescription for at least one red blood cell unit transfusion within 6 hours after trauma

• Delay between trauma and study randomization ≤ 6 hours

• Patient able to give consent or included in emergency situation

• Patient affiliated to Health security system

Exclusion Criteria:

• Age < 18 years

• Chronic kidney disease needing requiring renal replacement therapy

• Participation to another interventional trial interacting with renal function or which requires the use of a fluid resuscitation

• Fluid resuscitation > 4000 mL before inclusion