Inflammatory Consequences of Crystalloids in Severely Burned Patients

February 20, 2025 updated by: Centre hospitalier de l'Université de Montréal (CHUM)

Deciphering the Inflammatory Consequences of Crystalloids Used in the Resuscitation of Severely Burned Patients

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The investigators have 4 specific objectives. First, the investigators will compare the activation profiles of macrophages and neutrophils in patients admitted to the severely burned unit with regards to the crystalloids used. Secondly, the investigators will assess the differences in the SOFA scores according to the crystalloids used. Thirdly, the investigators will evaluate the impact of crystalloids in the quality of skin grafts performed on severely burned patients. Lastly, with the help of a patient partner, the investigators will determine the right immunological terminology of the study for a non-scientific population.

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montréal, Quebec, Canada, h2X0C1
        • CHUM

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PlasmaLyte
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
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).
Experimental: Ringer's Lactate
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
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in monocyte phenotype from admission to day 10
Time Frame: Pre-infusion to day 10 post-infusion
Following blood draws, monocytes will be subjected to flow cytometry for phenotype evaluation.
Pre-infusion to day 10 post-infusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Investigators

  • Principal Investigator: Jean-François Cailhier, MD, CRCHUM

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 17, 2021

Primary Completion (Actual)

February 19, 2025

Study Completion (Actual)

February 19, 2025

Study Registration Dates

First Submitted

May 12, 2021

First Submitted That Met QC Criteria

May 17, 2021

First Posted (Actual)

May 19, 2021

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 20, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20.443

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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