Burns
Conditions
Keywords
Albumin, Resuscitation, Pediatric Burns, Fluid creep, Shock, Crystalloids
Brief summary
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.
Detailed 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.
Interventions
BIOLOGICAL5% Albumin (human) Solution
Albumin is a biological product derived from human blood donors.
DRUGPaeds solution
Paeds solution contains dextrose 4.3%, and Sodium Chloride 0.18%
Sponsors
King Edward Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Years to 12 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Resuscitation Volume | 24-48 hours | Total volume of fluid required to maintain a urine output of 1-1.5ml/hour on the day 2 of admission. |
| Serum Albumin levels | 24-48 hours | Albumin level in patient after day 2 of admission |
| Urine Output | 24-48 hours | Amount of urine passed on day 2 of admission. Should be 1-2.5ml/kh/hr |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Requirement of inotropic support | 24-48 hours | Patients in shock not responding to additional fluid administration, with reduced urine output requiring dopamine or dobutamine. |
| Mortality | First 5 days of admission | Any death occuring within 5 days of admission |
Countries
Pakistan
Outcome results
None listed