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The Acute Burn ResUscitation Multicenter Prospective Trial

The Acute Burn ResUscitation Multicenter Prospective Trial

Recruiting
18 years and older
All
Phase N/A

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Overview

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.

Description

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 blockstratified 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.

Eligibility

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%)

Study details
    Burn Injury

NCT04356859

American Burn Association

18 February 2024

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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