Inflammatory Consequences of Crystalloids in Severely Burned Patients

Burns Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04893382
• Other study ID #: 20.443
• Status: Suspended
• Phase: N/A
• Start date: October 17, 2021
• Est. completion date: January 2025

Study information

• Verified date: February 2024
• Source: Centre hospitalier de l'Université de Montréal (CHUM)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 14
• Est. completion date: January 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Burns

Intervention

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).
• 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).

Locations

Country	Name	City	State
Canada	CHUM	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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