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Completed

NCT Number: NCT04356859

The Acute Burn ResUscitation Multicenter Prospective Trial

This is a prospective randomized multi-center study which will compare acute fluid resuscitation using a colloid strategy (LR + 5% Albumin) to a crystalloid strategy (LR alone), in adults with an acute burn involving at least 25% of their total body surface area.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alberta, Edmonton, Alberta, Canada

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About this study

Enrolled subjects will be randomly assigned to either the Colloid Group or the Crystalloid Group. Randomization will be based on an intent-to-treat basis. In order to ensure that the two groups have comparable injury severity at baseline, randomization will be block- stratified based on age (18-50 and > 50 years), burn size (25-50% and > 50% TBSA), and presence of inhalation injury confirmed by bronchoscopy (present or absent). In the Colloid Group resuscitation starts with LR and then 5% albumin will be introduced between 8 and 12 hours post burn in a ratio of 1/3 albumin to 2/3 LR. In the Crystalloid Group resuscitation is with LR only. Each group will have their study fluid maintained for the 1st 48 hours post burn and study fluids in each group will be identically titrated to the urinary output.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥ 18 years
  • Total burn size (second and third degree) is ≥ 25% of the TBSA
  • Burn center admission within 12 hours of injury.
  • There is a plan for formal fluid resuscitation.

Exclusion criteria

  • Significant associated trauma
  • High voltage (≥ 1000 volts) electrical burns
  • Burn wound excision surgery within 48 hours from injury
  • Fresh frozen plasma (FFP) given at any time ≤ 48 hours from injury
  • Hypertonic saline (HTS) given at any time ≤ 48 hours from injury
  • Hydroxyethyl starch (HES) given at any time ≤ 48 hours from injury
  • High dose Vitamin C infusion given at any time ≤ 48 hours from injury
  • Administration of human albumin prior to randomization
  • Palliative comfort measures are instituted ≤ 48 hours from injury
  • Pregnancy
  • Pre-injury chronic renal insufficiency equal to or greater than stage 3
  • Pre-injury chronic hepatic disease (Child-Pugh B or C)
  • Pre-injury left ventricular (LV) dysfunction (echocardiography LV grade II-IV or ejection fraction ≤ 35%)

Treatment and study plan

Albumin Human

Drug

Addition of albumin during acute resuscitation following burn injury

Other names: albumin

Primary outcomes

  1. Volume of fluid received during resuscitation for burn injury

    Time frame: 24 hours post burn injury

    Total fluid resuscitation volume at 24 hours post burn in mL/kg/% TBSA burn

Secondary outcomes

  1. Volume of fluid received during resuscitation for burn injury

    Time frame: 48 hours post burn injury

    Total resuscitation volume at 48 hours in mL/kg/%TBSA burn.

  2. Urine output during resuscitation for burn injury

    Time frame: 24 and 48 hours post burn injury

    Mean hourly urine output during resuscitation for burn injury

  3. Number of crossovers

    Time frame: 48 hours post burn injury

    Number of crossovers between study arms during resuscitation for burn injury

  4. Peak lactate and delta lactate

    Time frame: 48 hours post burn injury

    peak lactate level and delta lactate (peak lactate minus admission lactate)

  5. Peak intra-abdominal pressure (IAP) and delta IAP

    Time frame: 48 hours post burn injury

    Peak intra-abdominal pressure (IAP) and delta IAP (peak IAP minus admission IAP)

  6. Occurrence of Abdominal compartment syndrome

    Time frame: 48 hours post burn injury

    Abdominal compartment syndrome during resuscitation for burn injury

  7. Occurrence of Limb or abdominal fasciotomy

    Time frame: 48 hours post burn injury

    Limb or abdominal fasciotomy during resuscitation for burn injury

  8. Sequential Organ Failure Assessment (SOFA) score

    Time frame: 48, 72, and 96 hours post burn injury

    Assessment of organ function or failure by Sequential Organ Failure Assessment (SOFA)score, with the higher score(s) indicating organ failure

  9. Acute kidney injury (AKI)

    Time frame: 96 hours post burn injury

    Diagnosis of AKI

  10. Duration of intubation/mechanical ventilation

    Time frame: 96 hours post burn injury

    Duration of intubation/mechanical ventilation

  11. PaO2/FiO2 ratios

    Time frame: 24, 48, 72, and 96 hours post burn injury

    PaO2(partial pressure of oxygen)/FiO2(fraction of inspired oxygen inspired oxygen) ratios

  12. Time to wound healing

    Time frame: 7 days post last surgery for grafting of burn injury

    Time to wound healing defined as 7 days post last grafting surgery

  13. Survival

    Time frame: 28 days post injury and hospital discharge

    28 day survival and hospital stay survival

Sponsors and collaborators

Lead sponsor

American Burn Association

Other

Collaborators

  • United States Department of Defense

Registry information

Official study title

The Acute Burn ResUscitation Multicenter Prospective Trial (ABRUPT2)

Acronym: ABRUPT2

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Apr 22, 2020
Registry last updated
May 20, 2026

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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