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Crystalloid Solution
Fluid Resuscitation Solutions for Burns
N/A
Waitlist Available
Led By Jean-François Cailhier, MD
Research Sponsored by Centre hospitalier de l'Université de Montréal (CHUM)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-infusion to day 10 post-infusion
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing two types of fluids, PlasmaLyte and Ringer's Lactate, to see which one helps severely burned patients recover better by replacing lost fluids and maintaining body balance. PlasmaLyte has limited research in burn resuscitation, and further studies are needed to determine its suitability compared to Ringer's Lactate.
Who is the study for?
This trial is for severely burned patients with more than 20% of their body area affected, who can have their first blood sample taken within the first 24 hours after being burned. They must be admitted to CHUM. People cannot join if they are pregnant, had recent radiotherapy or chemotherapy, suffer from severe infections or major organ dysfunctions, Hepatitis C, HIV, cancer, immunosuppression or autoimmune diseases.
What is being tested?
The study is testing two types of fluids used in early treatment: PlasmaLyte and Ringer's Lactate. It aims to see how these fluids affect inflammation in patients with severe burns by observing changes in immune response and determining which fluid better prevents complications like macrophage hyperactivation.
What are the potential side effects?
While specific side effects aren't listed for this trial since it focuses on inflammatory responses rather than drug reactions, generally fluid resuscitation may cause issues such as electrolyte imbalances or allergic reactions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ pre-infusion to day 10 post-infusion
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-infusion to day 10 post-infusion
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in monocyte phenotype from admission to day 10
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Ringer's LactateExperimental Treatment1 Intervention
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.
Group II: PlasmaLyteExperimental Treatment1 Intervention
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.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Fluid resuscitation is a critical treatment for burn patients, aiming to restore intravascular volume, improve tissue perfusion, and prevent shock. Common fluids used include PlasmaLyte and Ringer's Lactate.
These solutions help to modulate the inflammatory response by maintaining electrolyte balance and preventing the hyperactivation of macrophages, which can lead to further tissue damage and systemic inflammation. Effective fluid resuscitation is essential for stabilizing burn patients, reducing the risk of multiple organ dysfunction, and improving overall outcomes.
[Effect of mannitol on serum tumor necrosis factor-α and interleukin-6 levels and the mechanism of its organ-protective effect in rabbits early after severe burn injury].
[Effect of mannitol on serum tumor necrosis factor-α and interleukin-6 levels and the mechanism of its organ-protective effect in rabbits early after severe burn injury].
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Who is running the clinical trial?
Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor
377 Previous Clinical Trials
131,366 Total Patients Enrolled
7 Trials studying Burns
295 Patients Enrolled for Burns
Jean-François Cailhier, MDPrincipal InvestigatorCRCHUM
1 Previous Clinical Trials
15 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are pregnant.You have a serious infection.You have a heart problem.You have burns on more than 20% of your body.You had radiation therapy within the past 6 months before the trial.You have a type of cancer.You have a weakened immune system.You have received chemotherapy within the last 6 months.You have an autoimmune disease.
Research Study Groups:
This trial has the following groups:- Group 1: PlasmaLyte
- Group 2: Ringer's Lactate
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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