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Inflammatory Consequences of Crystalloids in Severely Burned Patients

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04893382
Enrollment
14
Registered
2021-05-19
Start date
2021-10-17
Completion date
2025-02-19
Last updated
2025-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Burns

Keywords

Resuscitation, Crystalloids, Inflammation

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.

Interventions

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).

PROCEDURERinger'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).

Sponsors

Centre hospitalier de l'Université de Montréal (CHUM)
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in monocyte phenotype from admission to day 10Pre-infusion to day 10 post-infusionFollowing blood draws, monocytes will be subjected to flow cytometry for phenotype evaluation.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026