Clinical trial

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

Name
260/RC/KEMU
Description
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.
Trial arms
Trial start
2022-01-01
Estimated PCD
2022-12-18
Trial end
2023-05-17
Status
Completed
Phase
Early phase I
Treatment
5% Albumin (human) Solution
Albumin is a biological product derived from human blood donors.
Arms:
Albumin Group A
Other names:
ALBURX® 5
Paeds solution
Paeds solution contains dextrose 4.3%, and Sodium Chloride 0.18%
Arms:
Albumin Group A, Crystalloid Group B
Other names:
Revasol-Paeds IV Infusion
Size
90
Primary endpoint
Resuscitation Volume
24-48 hours
Serum Albumin levels
24-48 hours
Urine Output
24-48 hours
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 90, 'type': 'ACTUAL'}}
Updated at
2024-01-25

1 organization

2 products

1 indication

Product
5% Albumin
Indication
Burns