Fluid Resuscitation in Burn Patients

NCT03118362 | Completed Phase 3

• 1 other identifier: P160502
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Severe Burns; Fluid Resuscitation

Keywords

Burns; Critically ill; Acid-Base status

Outcome Measures

Primary Outcomes (1)

• The main endpoint is to compare the base deficit in patients receiving Plasmalyte® or Ringer lactate after 24 hours of admission.

  Arterial blood gas analysis

  after 24 hours of admission.

Secondary Outcomes (6)

• Acetate, gluconate and lactate clearance respectively in patients receiving Plasmalyte® or Ringer lactate.

  Every 6 hours for 48 hours, then every 12 hours for acid-base status during 5 days.

• acid-base status and strong ion difference after 24 hours of Plasmalyte® or Ringer lactate infusion

  Every 6 hours for 48 hours, then every 12 hours for acid-base status during 5 days.

• Occurrence of cardiac dysfunction, defined as altered left ventricular ejection fraction(<50%)

  Every day during 5 days

• Incidence of AKI (according to the KDIGO definition)

  Every day during 5 days

• Sequential Organ Failure Assessment score

  During the first 5 days of intensive care unit stay

Study Arms (2)

Plasmalyte®

EXPERIMENTAL

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.

Drug: Plasmalyte

Ringer Lactate®

EXPERIMENTAL

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.

Drug: Ringer lactate

Interventions

Plasmalyte 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.

Also known as: PLASMALYTE VIAFLO

Plasmalyte®

Ringer lactate 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.

Also known as: RINGER LACTATE VIAFLO

Ringer Lactate®

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients over 18 years
• TBSA\>30%
• Admission to an intensive care unit within 12 hours after burn injury
• social Insurance cover

You may not qualify if:

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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

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

Paris, 75010, France

Location

Related Publications (5)

• 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.

  PMID: 24318694 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

• 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.

  PMID: 24335444 BACKGROUND

• 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.

  PMID: 21235742 BACKGROUND

• 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.

  PMID: 19115651 BACKGROUND

MeSH Terms

Conditions

Burns; Critical Illness

Interventions

Plasmalyte A; Ringer's Lactate

Condition Hierarchy (Ancestors)

Wounds and Injuries; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Matthieu Legrand, MD, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: the crystalloid infusion solutions will be introduce in Opabag
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Plasmalyte® is a balanced solution containing a low chloride concentration (i.e. 98 mmol/L) which may overcome overwhelm the potential risks associated with hyperchloremic solutions. Plasmalyte® also contains acetate (27 mmol/L) and gluconate (23 mmol/L) as buffer solutions. Ringer Lactate® is also a balanced solution containing a low chloride concentration (i.e. 111 mmol/L)

Study Record Dates

• First Submitted: April 13, 2017
• First Posted: April 18, 2017
• Study Start: August 9, 2017
• Primary Completion: September 12, 2018
• Study Completion: December 2, 2019
• Last Updated: December 13, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)