Inflammatory Consequences of Crystalloids in Severely Burned Patients

Centre hospitalier de l'Université de Montréal (CHUM)

Status: Terminated

Conditions: Burns

Treatments: Procedure: Ringer's Lactate for fluid resuscitation; Procedure: PlasmaLyte for fluid resuscitation

Study type: Interventional

Funder types: Other

Identifiers

NCT04893382

20.443

Details and patient eligibility

About

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.

Full 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.

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

14 participants in 2 patient groups

PlasmaLyte

Experimental group

Description:

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(following randomization) during the resuscitation period following admission to the ICU. 50mL of blood will be withdrawn before the first infusion and for the following days (Day 1-2-5 and 10) in order to isolate neutrophils and monocytes.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.

Treatment:

Procedure: PlasmaLyte for fluid resuscitation

Ringer's Lactate

Experimental group

Description:

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.

Treatment:

Procedure: Ringer's Lactate for fluid resuscitation