What side effects are associated with this type of intervention?

The most common treatments for burns, particularly fluid resuscitation with crystalloids like PlasmaLyte and Ringer's Lactate, can have several side effects. These include fluid overload, which may cause pulmonary edema, and electrolyte imbalances, such as hyperchloremic metabolic acidosis. There is also a risk of infection and inflammation due to the invasive nature of fluid administration.

What prior FDA approvals exist?

FDA-approved treatments for burns primarily focus on fluid resuscitation to manage shock and prevent organ failure. PlasmaLyte and Ringer's Lactate are commonly used crystalloids for this purpose. These solutions help restore fluid balance and modulate the inflammatory response, which is crucial in the initial management of severe burns. While specific FDA approvals for these solutions in the context of burns are not detailed, their use is well-established in clinical practice for burn resuscitation.

What other types of research exist?

As of 2024, promising novel alternatives to PlasmaLyte and Ringer's Lactate for fluid resuscitation in burn patients include the use of balanced crystalloids with added anti-inflammatory agents or novel colloid solutions designed to modulate the inflammatory response. These alternatives aim to prevent macrophage hyperactivation and improve patient outcomes. Specific examples include solutions enriched with antioxidants or immunomodulatory compounds, which are currently under investigation in clinical trials.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-infusion to day 10 post-infusion for reporting.

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.

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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].