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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2023-05-17

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Burns

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Albumin Group A

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

Group Type EXPERIMENTAL

5% Albumin (human) Solution

Intervention Type BIOLOGICAL

Albumin is a biological product derived from human blood donors.

Paeds solution

Intervention Type DRUG

Paeds solution contains dextrose 4.3%, and Sodium Chloride 0.18%

Crystalloid Group B

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

Group Type ACTIVE_COMPARATOR

Paeds solution

Intervention Type DRUG

Paeds solution contains dextrose 4.3%, and Sodium Chloride 0.18%

Interventions

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5% Albumin (human) Solution

Albumin is a biological product derived from human blood donors.

Intervention Type BIOLOGICAL

Paeds solution

Paeds solution contains dextrose 4.3%, and Sodium Chloride 0.18%

Intervention Type DRUG

Other Intervention Names

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ALBURX® 5 Revasol-Paeds IV Infusion

Eligibility Criteria

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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.

Minimum Eligible Age

1 Year

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No