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CompletedNCT06224777Updated Jan 25, 2024

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

A Phase 2/3 interventional study of 5% Albumin (human) Solution and Paeds solution in Burns, sponsored by King Edward Medical University. Completed at 1 site in Pakistan. Open to participants aged 1 Year to 12 Years. Per ClinicalTrials.gov, last updated 2024-01-25.

Sponsored by King Edward Medical University · Phase 2/3, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years after the study started (first participant enrolled Jan 2022, registered Jan 2024).
Phase
Phase 2/3
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
1 Year to 12 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Burns

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Keywords

  • Albumin
  • Resuscitation
  • Pediatric Burns
  • Fluid creep
  • Shock
  • Crystalloids
03

In context

Burns

719 studies on the registry are indexed under Burns; 145 are open to participants now.

This study's enrollment of 90 is above the median of 40 across 524 interventional studies indexed under Burns.

Browse Burns studies →

Lead sponsor

King Edward Medical University is the lead sponsor of 78 studies on the registry; 24 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 25-40%, less than 12 hours old, scald or flame burn patients
  • Full thickness

Exclusion criteria

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.
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
90 participants (actual)

Study arms

  • 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.

    Biological: 5% Albumin (human) Solution · Drug: Paeds solution

  • Active comparator
    Crystalloid Group B

    Routine Crystalloids will be administered according to weight of the patient.

    Drug: Paeds solution

Interventions

  • Biological5% Albumin (human) Solution

    Albumin is a biological product derived from human blood donors.

    Also known as: ALBURX® 5

  • DrugPaeds solution

    Paeds solution contains dextrose 4.3%, and Sodium Chloride 0.18%

    Also known as: Revasol-Paeds IV Infusion

06

What researchers measure

Primary outcomes

  1. Resuscitation Volume

    Total volume of fluid required to maintain a urine output of 1-1.5ml/hour on the day 2 of admission.

    Time frame: 24-48 hours

  2. Serum Albumin levels

    Albumin level in patient after day 2 of admission

    Time frame: 24-48 hours

  3. Urine Output

    Amount of urine passed on day 2 of admission. Should be 1-2.5ml/kh/hr

    Time frame: 24-48 hours

Secondary outcomes

  1. Requirement of inotropic support

    Patients in shock not responding to additional fluid administration, with reduced urine output requiring dopamine or dobutamine.

    Time frame: 24-48 hours

  2. Mortality

    Any death occuring within 5 days of admission

    Time frame: First 5 days of admission

07

Study locations

1 site
  • King Edward Medical University, Mayo Hospital
    Lahore, Punjab 54000, Pakistan
08

References and documents

Publications

  • 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. PubMed 28879205 ↗
  • 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. PubMed 15920417 ↗
  • 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. PubMed 33658146 ↗

Related links

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 25, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06224777
Lead sponsor
King Edward Medical University
Responsible party
Sponsor
First posted
Jan 25, 2024
Start date
Jan 1, 2022
Primary completion
Dec 18, 2022
Completion
May 17, 2023
Last update
Jan 25, 2024

Study contacts

Fatima Naumeri, MBBS,FCPS
principal investigator · King Edward Medical University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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