Burns, Shock
Conditions
Keywords
albumin, resuscitation, burns, shock, fluid creep
Brief summary
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
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: 1. Subjects that received crystalloids only compared to subjects that received crystalloids plus albumin. 2. 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). 3. Characteristics of resuscitation prior to the start of albumin (pre-albumin) compared to characteristics of resuscitation following initiation of albumin (post albumin).
Interventions
None listed
Sponsors
U.S. Army Medical Research Acquisition Activity
University of California, Davis
American Burn Association
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fluid resuscitation volume | 24 hours post burn injury | Total fluid resuscitation volume in mL/kg/% TBSA (total body surface area) burn |
| albumin : crystalloid ratio | 24 hours hours post burn injury | albumin : crystalloid ratio ( mL albumin : mL crystalloid, and, grams albumin : mL crystalloid) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fasciotomy | during the first 48 hours post burn injury | Documentation of fasciotomy performed |
| abdominal compartment syndrome | during the first 48 hours post burn injury | Occurrence of abdominal compartment syndrome |
| completion of resuscitation | up to 48 hours post burn injury | Time to completion of resuscitation |
| AKIN Score (acute kidney injury network) | 24 hours post burn injury | Acute Kidney Injury Network stage |
| AKIN Score | 48 hours post burn injury | Acute Kidney Injury Network stage |
| I/O Ratio | 24 hours post burn injury | Total intake and output ratio |
| SOFA score | 48 hours post burn injury | Sequential Organ Failure Assessment |
| Mechanical Ventilation | from date of hospital admit until date of hospital discharge, assessed over duration of hospitalization up to 12 months | Duration of mechanical ventilation and ventilator free days |
| Hospital Stay | from date of hospital admit until date of hospital discharge, assessed over duration of hospitalization up to 12 months | Length of hospital stay |
| Survival | 28 days post burn injury or death, whichever occurs first | In hospital and 28 day survival |
| SOFA score (sequential organ failure assessment) | 24 hours post burn injury | Sequential Organ Failure Assessment |
| Doses of vasopressors and inotropes | 24 hours post burn injury | Total doses of vasopressors and inotropes |
Countries
United States
Outcome results
None listed