Inflammatory Consequences of Crystalloids in Severely Burned Patients

• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM) (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04893382
• Collaborator: (none)
• Enrollment: 14
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 13.5
• Patients Per Site Per Month: 1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Burns	Procedure: PlasmaLyte for fluid resuscitation; Procedure: Ringer's Lactate for fluid resuscitation	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 14 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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.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 (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Deciphering the Inflammatory Consequences of Crystalloids Used in the Resuscitation of Severely Burned Patients
• Actual Study Start Date: Oct 17, 2021
• Anticipated Primary Completion Date: Nov 1, 2022
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PlasmaLyte 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; 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).
Experimental: Ringer's Lactate 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; 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).

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHUM	Montréal	Quebec	Canada	h2X0C1

Sponsors and Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre hospitalier de l'Université de Montréal (CHUM)
• ClinicalTrials.gov Identifier: NCT04893382
• Other Study ID Numbers: 20.443
• First Posted: May 19, 2021
• Last Update Posted: Jul 20, 2022
• Last Verified: Jul 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Centre hospitalier de l'Université de Montréal (CHUM): Resuscitation; Crystalloids; Inflammation
• Additional relevant MeSH terms: Plasma-lyte 148

Study Results

No Results Posted as of Jul 20, 2022