Plasmalyte Versus Saline in Trauma Patients

NCT03630224 | Terminated Phase 3

• 2 other identifiers: P160919J2017-004206-17
• Study Type: interventional
• Target: 365
• Locations: 1 country
• Sites: 1

Brief 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%)?

Conditions

Severe Trauma Patients; Acute Kidney Injury

Keywords

Severe trauma; Acute kidney injury; Fluid resuscitation; Sodium chloride; Plasmalyte

Outcome Measures

Primary Outcomes (1)

• Proportion of Acute Kidney Injury (stage 2 or 3 according to KDIGO classification) over the 5 first days after trauma

  over the 5 first days after trauma

Secondary Outcomes (6)

• Proportion of patients requiring renal replacement therapy (during 28 days)

  during 28 days

• Amount of transfused blood product units (during the first 5 days)

  during the first 5 days

• Number of days alive without free of mechanical ventilation (during 28 days)

  during 28 days

• Days spent alive outside the ICU (during 28 days)

  during 28 days

• Mortality

  at 28 days

Study Arms (2)

Plasmalyte Viaflo

EXPERIMENTAL

Intervention type: drug (Plasmalyte Viaflo) Intervention name: plasmalyte Intervention description: fluid resuscitation using exclusively Plasmalyte up to 20L during the first 5 days

Drug: Plasmalyte Viaflo

NaCl 0.9%

ACTIVE COMPARATOR

Intervention type: drug (NaCl 0.9%) Intervention name: NaCl 0.9% Intervention description: fluid resuscitation using exclusively NaCl 0.9% up to 20L during the first 5 days

Drug: NaCl 0.9%

Interventions

Plasmalyte Viaflo DRUG

Intervention description: fluid resuscitation using exclusively Plasmalyte up to 20L during the first 5 days

Plasmalyte Viaflo

NaCl 0.9% DRUG

Intervention name: NaCl 0.9% Intervention description: fluid resuscitation using exclusively NaCl 0.9% up to 20L during the first 5 days

NaCl 0.9%

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Département d'Anesthésie Réanimation - Kremlin Bicêtre

Le Kremlin-Bicêtre, 94270, France

Location

Related Publications (10)

• Chowdhury AH, Cox EF, Francis ST, Lobo DN. A randomized, controlled, double-blind crossover study on the effects of 2-L infusions of 0.9% saline and plasma-lyte(R) 148 on renal blood flow velocity and renal cortical tissue perfusion in healthy volunteers. Ann Surg. 2012 Jul;256(1):18-24. doi: 10.1097/SLA.0b013e318256be72.

  PMID: 22580944 BACKGROUND

• Shaw AD, Bagshaw SM, Goldstein SL, Scherer LA, Duan M, Schermer CR, Kellum JA. Major complications, mortality, and resource utilization after open abdominal surgery: 0.9% saline compared to Plasma-Lyte. Ann Surg. 2012 May;255(5):821-9. doi: 10.1097/SLA.0b013e31825074f5.

  PMID: 22470070 BACKGROUND

• Yunos NM, Bellomo R, Hegarty C, Story D, Ho L, Bailey M. Association between a chloride-liberal vs chloride-restrictive intravenous fluid administration strategy and kidney injury in critically ill adults. JAMA. 2012 Oct 17;308(15):1566-72. doi: 10.1001/jama.2012.13356.

  PMID: 23073953 BACKGROUND

• Shaw AD, Raghunathan K, Peyerl FW, Munson SH, Paluszkiewicz SM, Schermer CR. Association between intravenous chloride load during resuscitation and in-hospital mortality among patients with SIRS. Intensive Care Med. 2014 Dec;40(12):1897-905. doi: 10.1007/s00134-014-3505-3. Epub 2014 Oct 8.

  PMID: 25293535 BACKGROUND

• Raghunathan K, Shaw A, Nathanson B, Sturmer T, Brookhart A, Stefan MS, Setoguchi S, Beadles C, Lindenauer PK. Association between the choice of IV crystalloid and in-hospital mortality among critically ill adults with sepsis*. Crit Care Med. 2014 Jul;42(7):1585-91. doi: 10.1097/CCM.0000000000000305.

  PMID: 24674927 BACKGROUND

• Shaw AD, Schermer CR, Lobo DN, Munson SH, Khangulov V, Hayashida DK, Kellum JA. Impact of intravenous fluid composition on outcomes in patients with systemic inflammatory response syndrome. Crit Care. 2015 Sep 12;19(1):334. doi: 10.1186/s13054-015-1045-z.

  PMID: 26370823 BACKGROUND

• Krajewski ML, Raghunathan K, Paluszkiewicz SM, Schermer CR, Shaw AD. Meta-analysis of high- versus low-chloride content in perioperative and critical care fluid resuscitation. Br J Surg. 2015 Jan;102(1):24-36. doi: 10.1002/bjs.9651. Epub 2014 Oct 30.

  PMID: 25357011 BACKGROUND

• Young P, Bailey M, Beasley R, Henderson S, Mackle D, McArthur C, McGuinness S, Mehrtens J, Myburgh J, Psirides A, Reddy S, Bellomo R; SPLIT Investigators; ANZICS CTG. Effect of a Buffered Crystalloid Solution vs Saline on Acute Kidney Injury Among Patients in the Intensive Care Unit: The SPLIT Randomized Clinical Trial. JAMA. 2015 Oct 27;314(16):1701-10. doi: 10.1001/jama.2015.12334.

  PMID: 26444692 BACKGROUND

• Bagshaw SM, George C, Gibney RT, Bellomo R. A multi-center evaluation of early acute kidney injury in critically ill trauma patients. Ren Fail. 2008;30(6):581-9. doi: 10.1080/08860220802134649.

  PMID: 18661407 BACKGROUND

• Bihorac A, Delano MJ, Schold JD, Lopez MC, Nathens AB, Maier RV, Layon AJ, Baker HV, Moldawer LL. Incidence, clinical predictors, genomics, and outcome of acute kidney injury among trauma patients. Ann Surg. 2010 Jul;252(1):158-65. doi: 10.1097/SLA.0b013e3181deb6bc.

  PMID: 20562612 BACKGROUND

MeSH Terms

Conditions

Acute Kidney Injury; Wounds and Injuries

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Anatole HARROIS

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2018
• First Posted: August 14, 2018
• Study Start: June 24, 2019
• Primary Completion: August 18, 2023
• Study Completion: August 18, 2023
• Last Updated: January 31, 2024

Record last verified: 2024-01

Locations

FR (1)