NCT04356859

The Acute Burn ResUscitation Multicenter Prospective Trial

The Acute Burn ResUscitation Multicenter Prospective Trial (ABRUPT2)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: American Burn Association · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 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.

Conditions

• Burn Injury

Interventions

Type	Name	Description
DRUG	Albumin Human	Addition of albumin during acute resuscitation following burn injury

Timeline

• Start date: 2021-04-22
• Primary completion: 2025-08-01
• Completion: 2025-09-01
• First posted: 2020-04-22
• Last updated: 2024-02-01

Locations

26 sites across 2 countries: United States, Canada