The Acute Burn Resuscitation Multicenter Prospective Observational Trial

Study Overview
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Brief Summary
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This is a prospective, non-interventional, observational study of consecutive burn patients admitted to 20 selected burn centers in North America. Primarily, data collection will be continuous real-time documentation of fluid infusion rates, vital signs and laboratory values of patients receiving fluid resuscitation during the first 48 hours following burn injury. All aspects of the resuscitation and all investigations performed will be according to the participating center's regular protocol, as this is purely an observational and non-interventional study. Further data collection on outcomes (organ function, ventilation duration, length of stay, and survival) will be collected at 72h, 96 h, and at hospital discharge.

Detailed Description
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This is a prospective observational study with no intervention. Study sites have been selected to include wide cross-representation of resuscitation practices using crystalloids alone, crystalloid plus albumin, and among sites that use albumin, variable approaches to the timing of albumin initiation. Detailed data will be continuously collected in real time during fluid resuscitation over the 1st 48 hours following a burn injury. Data collection during this phase will be done prospectively, hour-by-hour, by the bedside nurse caring for the patient. Primarily this data collection will involve recording of resuscitation fluid volumes, urinary output, vital signs (heart rate and blood pressure), and use of vasopressors and inotropes. Outcome data (organ function, need for mechanical ventilation, hospital length of stay, and survival) will be collected at various time points during the subjects' acute care stay. At completion of the study we intend to make the following comparisons: Subjects that received crystalloids only compared to subjects that received crystalloids plus albumin. Subjects that had albumin started early (< 8 hours post burn), compared to subjects that had albumin started intermediate (8-12 hours post burn), compared to subjects that had albumin started late (>12 hours post burn). Characteristics of resuscitation prior to the start of albumin (pre-albumin) compared to characteristics of resuscitation following initiation of albumin (post albumin).

Official Title
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The Acute Burn Resuscitation Multicenter Prospective Observational Trial

Conditions
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Burns, Shock

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years ≥ 20% TBSA burns Admitted to the burn center ≤ 12 post injury Exclusion Criteria: Significant associated trauma High voltage (≥ 1000 volts) electrical burns Surgery anticipated within 48 hours from injury Fresh frozen plasma (FFP) anticipated to be given at any time ≤ 48 hours from injury Hypertonic saline (HTS) anticipated to be given at any time ≤ 48 hours from injury Hydroxyethyl starch (HES) anticipated to be given at any time ≤ 48 hours from injury High dose Vitamin C infusion is anticipated to be given at any time ≤ 48 hours from injury Death occurs or comfort measures are instituted within ≤ 48 hours from injury

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Burns<br>Patients with burns to 20% or more of their BSA (body surface area) require resuscitation with intravenous crystalloid fluids in order to avoid organ failure and death | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fluid resuscitation volume | Total fluid resuscitation volume in mL/kg/% TBSA (total body surface area) burn | 24 hours post burn injury | 
| albumin : crystalloid ratio | albumin : crystalloid ratio ( mL albumin : mL crystalloid, and, grams albumin : mL crystalloid) | 24 hours hours post burn injury | 
| Fluid resuscitation volume | Total fluid resuscitation volume in mL/kg/% TBSA burn | 48 hours post burn injury | 
| albumin : crystalloid ratio | albumin : crystalloid ratio ( mL albumin : mL crystalloid, and, grams albumin : mL crystalloid) | 48 hours post burn injury | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| I/O Ratio | Total intake and output ratio | 24 hours post burn injury | 
| I/O Ratio | Total intake and output ratio | 48 hours post burn injury | 
| Doses of vasopressors and inotropes | Total doses of vasopressors and inotropes | 24 hours post burn injury | 
| Doses of vasopressors and inotropes | Total doses of vasopressors and inotropes | 48 hours post burn injury | 
| Fasciotomy | Documentation of fasciotomy performed | during the first 48 hours post burn injury | 
| abdominal compartment syndrome | Occurrence of abdominal compartment syndrome | during the first 48 hours post burn injury | 
| completion of resuscitation | Time to completion of resuscitation | up to 48 hours post burn injury | 
| AKIN Score (acute kidney injury network) | Acute Kidney Injury Network stage | 24 hours post burn injury | 
| AKIN Score | Acute Kidney Injury Network stage | 48 hours post burn injury | 
| AKIN Score | Acute Kidney Injury Network stage | 72 hours post burn injury | 
| AKIN Score | Acute Kidney Injury Network stage | 96 hours post burn injury | 
| SOFA score (sequential organ failure assessment) | Sequential Organ Failure Assessment | 24 hours post burn injury | 
| SOFA score | Sequential Organ Failure Assessment | 48 hours post burn injury | 
| SOFA score | Sequential Organ Failure Assessment | 72 hours post burn injury | 
| SOFA score | Sequential Organ Failure Assessment | 96 hours post burn injury | 
| Mechanical Ventilation | Duration of mechanical ventilation and ventilator free days | from date of hospital admit until date of hospital discharge, assessed over duration of hospitalization up to 12 months | 
| Hospital Stay | Length of hospital stay | from date of hospital admit until date of hospital discharge, assessed over duration of hospitalization up to 12 months | 
| Survival | In hospital and 28 day survival | 28 days post burn injury or death, whichever occurs first | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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albumin, resuscitation, burns, shock, fluid creep