Inflammatory Consequences of Crystalloids in Severely Burned Patients

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Burns

Intervention / Treatment
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* Procedure: PlasmaLyte for fluid resuscitation
* Procedure: Ringer's Lactate for fluid resuscitation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PlasmaLyte<br>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<br>* 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).<br>|
| Experimental: Ringer's Lactate<br>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<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Resuscitation, Crystalloids, Inflammation