King Edward Medical University, Mayo Hospital
Lahore, Punjab Province, 54000, Pakistan
NCT Number: NCT06224777
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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Notify Me1 year–12 year
All sexes
Interventional
Phase 2 / Phase 3
Lahore, Punjab Province, 54000, Pakistan
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Albumin is a biological product derived from human blood donors.
Other names: ALBURX® 5
Paeds solution contains dextrose 4.3%, and Sodium Chloride 0.18%
Other names: Revasol-Paeds IV Infusion
Time frame: 24-48 hours
Total volume of fluid required to maintain a urine output of 1-1.5ml/hour on the day 2 of admission.
Time frame: 24-48 hours
Albumin level in patient after day 2 of admission
Time frame: 24-48 hours
Amount of urine passed on day 2 of admission. Should be 1-2.5ml/kh/hr
Time frame: 24-48 hours
Patients in shock not responding to additional fluid administration, with reduced urine output requiring dopamine or dobutamine.
Time frame: First 5 days of admission
Any death occuring within 5 days of admission
King Edward Medical University
Other
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