Inflammatory Consequences of Crystalloids in Severely Burned Patients

Not Applicable

Terminated

• Conditions: Burns
• Interventions: Procedure: Ringer's Lactate for fluid resuscitation; Procedure: PlasmaLyte for fluid resuscitation

• Registration Number: NCT04893382
• Lead Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

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.

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 Timeline

• Study First Submitted: 2021-05-12
• Study First Submitted QC: 2021-05-17
• Study First Posted: 2021-05-19
• Study Start: 2021-10-17
• Status Verified: 2025-02
• Primary Completion: 2025-02-19
• Study Completion: 2025-02-19
• Last Update Submitted: 2025-02-20
• Last Update Posted: 2025-02-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 14

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ringer's Lactate	Ringer's Lactate for fluid resuscitation	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.
PlasmaLyte	PlasmaLyte for fluid resuscitation	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.

Primary Outcome Measures

Name	Time	Method
Change in monocyte phenotype from admission to day 10	Pre-infusion to day 10 post-infusion	Following blood draws, monocytes will be subjected to flow cytometry for phenotype evaluation.

Trial Locations

Locations (1)

CHUM; 🇨🇦 Montréal, Quebec, Canada