Comparison of Fluid Resuscitation in Pediatric Burn Patients Using Crystalloids and With Albumin on Day Two.
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
-
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Punjab
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Lahore, Punjab, Pakistan, 54000
- King Edward Medical University, Mayo Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Albumin Group A
5% Albumin solution will be administered on day 2 @0.5ml/kg/%burn over 8 hours,in addition to required crystalloids.
|
Albumin is a biological product derived from human blood donors.
Other Names:
Paeds solution contains dextrose 4.3%, and Sodium Chloride 0.18%
Other Names:
|
|
Active Comparator: Crystalloid Group B
Routine Crystalloids will be administered according to weight of the patient.
|
Paeds solution contains dextrose 4.3%, and Sodium Chloride 0.18%
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Resuscitation Volume
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.
|
24-48 hours
|
|
Serum Albumin levels
Time Frame: 24-48 hours
|
Albumin level in patient after day 2 of admission
|
24-48 hours
|
|
Urine Output
Time Frame: 24-48 hours
|
Amount of urine passed on day 2 of admission.
Should be 1-2.5ml/kh/hr
|
24-48 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Requirement of inotropic support
Time Frame: 24-48 hours
|
Patients in shock not responding to additional fluid administration, with reduced urine output requiring dopamine or dobutamine.
|
24-48 hours
|
|
Mortality
Time Frame: First 5 days of admission
|
Any death occuring within 5 days of admission
|
First 5 days of admission
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Fatima Naumeri, MBBS,FCPS, King Edward Medical University
Publications and helpful links
General Publications
- O'Mara MS, Slater H, Goldfarb IW, Caushaj PF. A prospective, randomized evaluation of intra-abdominal pressures with crystalloid and colloid resuscitation in burn patients. J Trauma. 2005 May;58(5):1011-8. doi: 10.1097/01.ta.0000162732.39083.15.
- Romanowski KS, Palmieri TL. Pediatric burn resuscitation: past, present, and future. Burns Trauma. 2017 Sep 4;5:26. doi: 10.1186/s41038-017-0091-y. eCollection 2017.
- Comish P, Walsh M, Castillo-Angeles M, Kuhlenschmidt K, Carlson D, Arnoldo B, Kubasiak J. Adoption of rescue colloid during burn resuscitation decreases fluid administered and restores end-organ perfusion. Burns. 2021 Dec;47(8):1844-1850. doi: 10.1016/j.burns.2021.02.005. Epub 2021 Feb 20.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 260/RC/KEMU
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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