Comparison of Fluid Resuscitation in Pediatric Burn Patients Using Crystalloids and With Albumin on Day Two.

King Edward Medical University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Burns

Treatments: Biological: 5% Albumin (human) Solution; Drug: Paeds solution

Study type: Interventional

Funder types: Other

Identifiers

NCT06224777

260/RC/KEMU

Details and patient eligibility

About

The goal of this comparative, interventional randomized controlled trial is to use albumin during resuscitation in pediatric burn patients on day 2, as it can reduce extravasation of fluids and decrease the overall fluid requirements, along with mortality and maintain circulation.

Participants will be divided into 2 groups. Albumin will be administered additionally in group A, while only crystalloids will be used for resuscitation in group B.

Full description

The randomized controlled trial will be done at Department of Pediatric Surgery, Mayo Hospital Lahore from January 2022 to December 2022. Ninety patients (forty-five patients in each group) will be enrolled using a non probability convenient sampling technique. Patients will be randomly divided into 2 groups. Albumin solution will be administered in group A and in group B only routine crystalloids will be given. Basic demographic information will be noted. Effect modifiers (hemoglobin, Albumin level, weight and height) will be noted.

Group A: After first 24 hours, maintenance fluid, N/2+5%Dextrose solution will be started according to weight(100ml/kg/day for first 10kg, 50ml/kg/day for next 10kg and 20ml/kg/day for the remainder) and will be increased or decreased by 1/3 to maintain the urinary output to 1-1.5ml/kg/hour. 12, 75 5% Albumin solution will be administered @0.5ml/kg/%burn over initial 8 hours of day 2 and It's amount will be subtracted from the 24 hours fluid calculated earlier.

Group B: After first 24 hours, maintenance fluid, N/2+5%Dextrose solution will be started according to weight (100ml/kg/day for first 10kg, 50ml/kg/day for next 10kg and 20ml/kg/day for the remainder) and will be increased or decreased by 1/3 to maintain the urinary output to 1-1.5ml/kg/hour.

Enrollment: 90 patients

Sex: All

Ages: 1 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 25-40%, less than 12 hours old, scald or flame burn patients
• Full thickness

Exclusion criteria

• Burns with inhalational injury.
• Patients hypersensitive to Albumin.
• Deranged renal or hepatic profile.
• Patients with known Cardiac or debilitating Congenital anomalies.
• Patients with known metabolic disease.
• Burns associated with trauma including fractures, head injuries, intra-abdominal bleed etc.
• Albumin level lower than 1.8g/dl at time of admission.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 2 patient groups

Albumin Group A

Experimental group

Description:

5% Albumin solution will be administered on day 2 @0.5ml/kg/%burn over 8 hours,in addition to required crystalloids.

Treatment:

Drug: Paeds solution

Biological: 5% Albumin (human) Solution

Crystalloid Group B

Active Comparator group

Description:

Routine Crystalloids will be administered according to weight of the patient.

Treatment:

Drug: Paeds solution