The Acute Burn ResUscitation Multicenter Prospective Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Acute Burn ResUscitation Multicenter Prospective Trial (ABRUPT2)

Conditions
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Burn Injury

Intervention / Treatment
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* Drug: Albumin Human


Participation Criteria
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Eligibility Criteria
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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%)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomization will be based on intent to treat. Consecutively admitted and eligible burn patients will be assigned to one of two treatment groups (Colloid or Crystalloid) within 12 hours of burn injury.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Crystalloid<br>Subjects in the crystalloid group will receive fluid resuscitation with Lactated Ringer's titrated each hour to achieve a urine output of 0.5-1mL/kg predicted body weight. | |
| Active Comparator: Colloid<br>Subjects in the colloid group will receive fluid resuscitation with Lactated Ringer's and 5% human albumin solution introduced no earlier than 8 hours post burn and no later than 12 hours post burn in a ratio by volume of 1/3 albumin to 2/3 Lactated Ringer's, and titrated each hour to achieve a urine output of 0.5-1mL/kg (milliliter/kilogram) predicted body weight. | Drug: Albumin Human<br>* Addition of albumin during acute resuscitation following burn injury<br>* Other names: albumin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Volume of fluid received during resuscitation for burn injury | Total fluid resuscitation volume at 24 hours post burn in mL/kg/% TBSA burn | 24 hours post burn injury | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Volume of fluid received during resuscitation for burn injury | Total resuscitation volume at 48 hours in mL/kg/%TBSA burn. | 48 hours post burn injury | 
| Urine output during resuscitation for burn injury | Mean hourly urine output during resuscitation for burn injury | 24 and 48 hours post burn injury | 
| Number of crossovers | Number of crossovers between study arms during resuscitation for burn injury | 48 hours post burn injury | 
| Peak lactate and delta lactate | peak lactate level and delta lactate (peak lactate minus admission lactate) | 48 hours post burn injury | 
| Peak intra-abdominal pressure (IAP) and delta IAP | Peak intra-abdominal pressure (IAP) and delta IAP (peak IAP minus admission IAP) | 48 hours post burn injury | 
| Occurrence of Abdominal compartment syndrome | Abdominal compartment syndrome during resuscitation for burn injury | 48 hours post burn injury | 
| Occurrence of Limb or abdominal fasciotomy | Limb or abdominal fasciotomy during resuscitation for burn injury | 48 hours post burn injury | 
| Sequential Organ Failure Assessment (SOFA) score | Assessment of organ function or failure by Sequential Organ Failure Assessment (SOFA)score, with the higher score(s) indicating organ failure | 48, 72, and 96 hours post burn injury | 
| Acute kidney injury (AKI) | Diagnosis of AKI | 96 hours post burn injury | 
| Duration of intubation/mechanical ventilation | Duration of intubation/mechanical ventilation | 96 hours post burn injury | 
| PaO2/FiO2 ratios | PaO2(partial pressure of oxygen)/FiO2(fraction of inspired oxygen inspired oxygen) ratios | 24, 48, 72, and 96 hours post burn injury | 
| Time to wound healing | Time to wound healing defined as 7 days post last grafting surgery | 7 days post last surgery for grafting of burn injury | 
| Survival | 28 day survival and hospital stay survival | 28 days post injury and hospital discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Resuscitation