Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Sacramento, California
Dates
study started
estimated completion
Principal Investigator
David G Greenhalgh, MD

Description

Summary

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.

Official Title

The Acute Burn ResUscitation Multicenter Prospective Trial (ABRUPT2)

Details

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.

Keywords

Burn Injury Resuscitation Burns Albumin Human Crystalloid Colloid

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • 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%)

Location

  • University of California Davis, Regional Burn Center
    Sacramento California 95817 United States

Lead Scientist at UC Davis

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
American Burn Association
Links
Sign up for this study
ID
NCT04356859
Study Type
Interventional
Last Updated