Inflammatory Consequences of Crystalloids in Severely Burned Patients

NCT04893382 | Terminated

• 1 other identifier: 20.443
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

This is a pilot study, but the investigators will also observe key immunological events with potential significance. The global objective is to study the inflammatory profiles of PlasmaLyte and Ringer's Lactate used in the initial massive fluid resuscitation of severely burned patients. On the long term, the investigators will identify the crystalloid that prevents hyperactivation of macrophages and death of severely burned patients.

Conditions

Burns

Keywords

Resuscitation; Crystalloids; Inflammation

Outcome Measures

Primary Outcomes (1)

• Change in monocyte phenotype from admission to day 10

  Following blood draws, monocytes will be subjected to flow cytometry for phenotype evaluation.

  Pre-infusion to day 10 post-infusion

Study Arms (2)

PlasmaLyte

EXPERIMENTAL

Seven (7) severely burned patients will be infused with PlasmaLyte (following randomization) during the resuscitation period following admission to the ICU. 50mL of blood will be withdrawn before the first infusion and for the following days (Day 1-2-5 and 10) in order to isolate neutrophils and monocytes. Plasma will be preserved for future cytokines characterization.

Procedure: PlasmaLyte for fluid resuscitation

Ringer's Lactate

EXPERIMENTAL

Seven (7) severely burned patients will be infused with Ringer's Lactate (following randomization) during the resuscitation period following admission to the ICU. 50mL of blood will be withdrawn before the first infusion and for the following days (Day 1-2-5 and 10) in order to isolate neutrophils and monocytes. Plasma will be preserved for future cytokines characterization.

Procedure: Ringer's Lactate for fluid resuscitation

Interventions

PlasmaLyte for fluid resuscitation PROCEDURE

Fluid resuscitation is a critical and essential part in the treatment of severely burned patients. Patients randomized for this arm will be submitted to PlasmaLyte infusion (as clinically prescribed).

PlasmaLyte

Ringer's Lactate for fluid resuscitation PROCEDURE

Fluid resuscitation is a critical and essential part in the treatment of severely burned patients. Patients randomized for this arm will be submitted to Ringer's Lactate infusion (as clinically prescribed).

Ringer's Lactate

Eligibility Criteria

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

You may qualify if:

• admission to the CHUM
• more than 20% of burned area
• first blood withdrawal in the first 24 hours following burn

You may not qualify if:

• immunosuppression
• chemotherapy 6 months before admission
• radiotherapy 6 months before admission
• autoimmune diseases
• neoplasia
• pregnancy
• severe infections
• cardiac dysfunctions
• renal dysfunction
• hepatic dysfunctions
• Hepatitis C
• HIV

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead

Study Sites (1)

CHUM

Montreal, Quebec, h2X0C1, Canada

Location

MeSH Terms

Conditions

Burns; Inflammation

Interventions

Plasmalyte A; Ringer's Lactate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Jean-François Cailhier, MD

  CRCHUM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients admitted to the severely burned unit will be randomized by the research nurse to either received PlasmaLyte or Ringer's Lactate. Research Nurse will then advise the treating team.

Study Record Dates

• First Submitted: May 12, 2021
• First Posted: May 19, 2021
• Study Start: October 17, 2021
• Primary Completion: February 19, 2025
• Study Completion: February 19, 2025
• Last Updated: February 21, 2025

Record last verified: 2025-02

Locations

CA (1)