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Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT04893382
Other study ID # 20.443
Secondary ID
Status Suspended
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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