Comparison of Fluid Resuscitation in Pediatric Burn Patients Using Crystalloids and With Albumin on Day Two.

Burns Clinical Trial

Official title:

Comparison of Fluid Resuscitation in Pediatric Burn Patients Using Crystalloids and With Albumin on Day Two.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06224777
• Other study ID #: 260/RC/KEMU
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: January 1, 2022
• Est. completion date: May 17, 2023

Study information

• Verified date: September 2023
• Source: King Edward Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: May 17, 2023
• Est. primary completion date: December 18, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Burns

Intervention

Biological:
• 5% Albumin (human) Solution
Albumin is a biological product derived from human blood donors.

Drug:
• Paeds solution
Paeds solution contains dextrose 4.3%, and Sodium Chloride 0.18%

Locations

Country	Name	City	State
Pakistan	King Edward Medical University, Mayo Hospital	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
King Edward Medical University

Country where clinical trial is conducted

Pakistan, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resuscitation Volume	Total volume of fluid required to maintain a urine output of 1-1.5ml/hour on the day 2 of admission.	24-48 hours
Primary	Serum Albumin levels	Albumin level in patient after day 2 of admission	24-48 hours
Primary	Urine Output	Amount of urine passed on day 2 of admission. Should be 1-2.5ml/kh/hr	24-48 hours
Secondary	Requirement of inotropic support	Patients in shock not responding to additional fluid administration, with reduced urine output requiring dopamine or dobutamine.	24-48 hours
Secondary	Mortality	Any death occuring within 5 days of admission	First 5 days of admission

External Links

•   Rationale