Fluid Resuscitation in Burn Patients

NCT ID: NCT03118362

Last Updated: 2019-12-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-09
• Study Completion Date: 2019-12-02

Brief Summary

Balanced solutions with low chloride concentration could represent an alternative to high chloride concentration solutions. Such balanced solutions contain other acid as buffers (i.e. acetate and/or gluconate). However, acetate has been associated with alteration of cardiac function when used as buffer in dialysate when high acetate concentrations are used and could promote the development of metabolic acidosis if it accumulates. Therefore, the safety of such solutions remains poorly explored. Because critically ill patients receive large amount of fluid during the early phase of resuscitation, large amount of acetate are to be administrated if such solutions are used. While acetate-containing solutions have been suggested to be safe in this setting, studies are still lacking regarding clearance and accumulation in critically ill patients.

It is expected to include 28 patients, the objective to analyze the data of 20 patients.

Detailed Description

The main objectives of the study is 1) to determine whether Plasmalyte® promote the development of metabolic acidosis in comparison with an acetate-free balanced solutions: Ringer lactate (chloride concentration of 111 mmol/L) and 2) to determine Acetate & gluconate clearance during fluid resuscitation of severely burn patients Plasmalyte® (chloride concentration of 98 mmol/L) . Severely burn patients will be randomized to receive Plasmalyte® or Ringer Lactate for initial fluid resuscitation during the first 5 days following admission.

Conditions

Severe Burns; Fluid Resuscitation

Keywords

Burns; Critically ill; Acid-Base status

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Plasmalyte®

Plasmalyte® is a balanced solution containing a low chloride concentration (i.e. 98 mmol/L), it also contains acetate (27 mmol/L) and gluconate (23 mmol/L) as buffer solutions.

Group Type: EXPERIMENTAL

Plasmalyte

Intervention Type: DRUG

Parenteral administration of Plasmalyte initiated immediately after inclusion at a dosage of 4 ml / kg per percentage area of skin burned for the first 24 hours after burn injury and adjusted based on hemodynamic monitoring.

Each patient will receive this solution up to 5 days.

Ringer Lactate®

Ringer Lactate® is a balanced solution containing a low chloride concentration (i.e. 111mmol/L), it also contains lactate (29 mmol/L) as buffer solutions.

Group Type: EXPERIMENTAL

Ringer lactate

Intervention Type: DRUG

Parenteral administration of Ringer lactate initiated immediately after inclusion at a dosage of 4 ml / kg per percentage area of skin burned for the first 24 hours after burn injury and adjusted based on hemodynamic monitoring.

Each patient will receive this solution up to 5 days.

Interventions

Plasmalyte

Parenteral administration of Plasmalyte initiated immediately after inclusion at a dosage of 4 ml / kg per percentage area of skin burned for the first 24 hours after burn injury and adjusted based on hemodynamic monitoring.

Each patient will receive this solution up to 5 days.

Intervention Type: DRUG

Ringer lactate

Parenteral administration of Ringer lactate initiated immediately after inclusion at a dosage of 4 ml / kg per percentage area of skin burned for the first 24 hours after burn injury and adjusted based on hemodynamic monitoring.

Each patient will receive this solution up to 5 days.

Intervention Type: DRUG

Other Intervention Names

PLASMALYTE VIAFLO; RINGER LACTATE VIAFLO

Eligibility Criteria

Inclusion Criteria

• Patients over 18 years
• TBSA>30%
• Admission to an intensive care unit within 12 hours after burn injury
• Signed informed consent to Patient / Parent / ( Inclusion in Emergency and Consent is Collected)
• social Insurance cover

Exclusion Criteria

• Decline to participate
• pregnancy
• Metabolic alkalosis (excess of base> 5mmol / L)
• legal obstacle to participate

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Matthieu Legrand, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Departement of Anesthesiology, Critical Care and Burn Unit; Saint-Louis hospital, 1 Avenue Claude Vellefaux, 75010, Paris & University Paris Diderot

Locations

Departement of Anesthesiology, Critical Care and Burn Unit; Saint-Louis hospital

Paris, , France

Countries

France

References

Hahn RG. Should anaesthetists stop infusing isotonic saline? Br J Anaesth. 2014 Jan;112(1):4-6. doi: 10.1093/bja/aet292. No abstract available.

Reference Type: BACKGROUND

PMID: 24318694 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22470070 (View on PubMed)

Zhou F, Peng ZY, Bishop JV, Cove ME, Singbartl K, Kellum JA. Effects of fluid resuscitation with 0.9% saline versus a balanced electrolyte solution on acute kidney injury in a rat model of sepsis*. Crit Care Med. 2014 Apr;42(4):e270-8. doi: 10.1097/CCM.0000000000000145.

Reference Type: BACKGROUND

PMID: 24335444 (View on PubMed)

Davies PG, Venkatesh B, Morgan TJ, Presneill JJ, Kruger PS, Thomas BJ, Roberts MS, Mundy J. Plasma acetate, gluconate and interleukin-6 profiles during and after cardiopulmonary bypass: a comparison of Plasma-Lyte 148 with a bicarbonate-balanced solution. Crit Care. 2011;15(1):R21. doi: 10.1186/cc9966. Epub 2011 Jan 14.

Reference Type: BACKGROUND

PMID: 21235742 (View on PubMed)

Morgan TJ, Power G, Venkatesh B, Jones MA. Acid-base effects of a bicarbonate-balanced priming fluid during cardiopulmonary bypass: comparison with Plasma-Lyte 148. A randomised single-blinded study. Anaesth Intensive Care. 2008 Nov;36(6):822-9. doi: 10.1177/0310057X0803600611.

Reference Type: BACKGROUND

PMID: 19115651 (View on PubMed)

Other Identifiers

P160502

Identifier Type: -

Identifier Source: org_study_id