Comparison of Fluid Resuscitation in Pediatric Burn Patients Using Crystalloids and With Albumin on Day Two.
- Conditions
- Burns
- Interventions
- Biological: 5% Albumin (human) SolutionDrug: Paeds solution
- Registration Number
- NCT06224777
- Lead Sponsor
- King Edward Medical University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 90
- 25-40%, less than 12 hours old, scald or flame burn patients
- Full thickness
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Albumin Group A Paeds solution 5% Albumin solution will be administered on day 2 @0.5ml/kg/%burn over 8 hours,in addition to required crystalloids. Crystalloid Group B Paeds solution Routine Crystalloids will be administered according to weight of the patient. Albumin Group A 5% Albumin (human) Solution 5% Albumin solution will be administered on day 2 @0.5ml/kg/%burn over 8 hours,in addition to required crystalloids.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Mortality First 5 days of admission Any death occuring within 5 days of admission
Requirement of inotropic support 24-48 hours Patients in shock not responding to additional fluid administration, with reduced urine output requiring dopamine or dobutamine.
Trial Locations
- Locations (1)
King Edward Medical University, Mayo Hospital
🇵🇰Lahore, Punjab, Pakistan