NCT06224777

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2022

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 18, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 17, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 16, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 25, 2024

Completed
Last Updated

January 25, 2024

Status Verified

September 1, 2023

Enrollment Period

12 months

First QC Date

January 16, 2024

Last Update Submit

January 16, 2024

Conditions

Burns

Keywords

AlbuminResuscitationPediatric BurnsFluid creepShockCrystalloids

Outcome Measures

Primary Outcomes (3)

  • 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

  • Serum Albumin levels

    Albumin level in patient after day 2 of admission

    24-48 hours

  • Urine Output

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

    24-48 hours

Secondary Outcomes (2)

  • Requirement of inotropic support

    24-48 hours

  • Mortality

    First 5 days of admission

Study Arms (2)

Albumin Group A

EXPERIMENTAL

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) SolutionDrug: Paeds solution

Crystalloid Group B

ACTIVE COMPARATOR

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

Drug: Paeds solution

Interventions

5% Albumin (human) SolutionBIOLOGICAL

Albumin is a biological product derived from human blood donors.

Also known as: ALBURX® 5
Albumin Group A
Paeds solutionDRUG

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

Also known as: Revasol-Paeds IV Infusion
Albumin Group ACrystalloid Group B

Eligibility Criteria

Age1 Year - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King Edward Medical University, Mayo Hospital

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (3)

  • 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.

    PMID: 28879205BACKGROUND

  • 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.

    PMID: 15920417BACKGROUND

  • 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.

    PMID: 33658146BACKGROUND

Related Links

MeSH Terms

Conditions

BurnsShock

Interventions

AlbuminsSolutions

Condition Hierarchy (Ancestors)

Wounds and InjuriesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ProteinsAmino Acids, Peptides, and ProteinsPharmaceutical Preparations

Study Officials

  • Fatima Naumeri, MBBS,FCPS

    King Edward Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2024

First Posted

January 25, 2024

Study Start

January 1, 2022

Primary Completion

December 18, 2022

Study Completion

May 17, 2023

Last Updated

January 25, 2024

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)