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Completed

NCT Number: NCT06224777

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.

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Key information

Age range

1 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

King Edward Medical University, Mayo Hospital

Lahore, Punjab Province, 54000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

5% Albumin (human) Solution

Biological

Albumin is a biological product derived from human blood donors.

Other names: ALBURX® 5

Paeds solution

Drug

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

Other names: Revasol-Paeds IV Infusion

Primary outcomes

  1. 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.

  2. Serum Albumin levels

    Time frame: 24-48 hours

    Albumin level in patient after day 2 of admission

  3. Urine Output

    Time frame: 24-48 hours

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

Secondary outcomes

  1. 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.

  2. Mortality

    Time frame: First 5 days of admission

    Any death occuring within 5 days of admission

Sponsors and collaborators

Lead sponsor

King Edward Medical University

Other

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Jan 25, 2024
Registry last updated
Jan 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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