Clinical trial NCT06224777: Comparison of Fluid Resuscitation in Pediatric Burn Patients Using Crystalloids and With Albumin on Day Two.
Official title: Comparison of Fluid Resuscitation in Pediatric Burn Patients Using Crystalloids and With Albumin on Day Two.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Burns
Keywords: Albumin
Resuscitation
Pediatric Burns
Fluid creep
Shock
Crystalloids
Lead sponsor: King Edward Medical University
Sponsor class: OTHER
First posted: 2024-01-25
Enrollment: 90
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Resuscitation Volume
timeFrame: 24-48 hours
measure: Serum Albumin levels
timeFrame: 24-48 hours
measure: Urine Output
timeFrame: 24-48 hours
Secondary outcomes:
measure: Requirement of inotropic support
timeFrame: 24-48 hours
measure: Mortality
timeFrame: First 5 days of admission
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: King Edward Medical University, Mayo Hospital
state: Punjab
Study officials:
affiliation: King Edward Medical University
name: Fatima Naumeri, MBBS,FCPS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.