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Completed

NCT Number: NCT03144427

The Acute Burn Resuscitation Multicenter Prospective Observational Trial

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.

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Key information

Conditions

Burns Pathologic Processes Pathological Conditions, Signs and Symptoms Shock Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of California Davis Medical Center-Regional Burn Center

Sacramento, California, 95817, United States

About this study

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").

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Fluid resuscitation volume

    Time frame: 24 hours post burn injury

    Total fluid resuscitation volume in mL/kg/% TBSA (total body surface area) burn

  2. albumin : crystalloid ratio

    Time frame: 24 hours hours post burn injury

    albumin : crystalloid ratio ( mL albumin : mL crystalloid, and, grams albumin : mL crystalloid)

  3. Fluid resuscitation volume

    Time frame: 48 hours post burn injury

    Total fluid resuscitation volume in mL/kg/% TBSA burn

  4. albumin : crystalloid ratio

    Time frame: 48 hours post burn injury

    albumin : crystalloid ratio ( mL albumin : mL crystalloid, and, grams albumin : mL crystalloid)

Secondary outcomes

  1. I/O Ratio

    Time frame: 24 hours post burn injury

    Total intake and output ratio

  2. I/O Ratio

    Time frame: 48 hours post burn injury

    Total intake and output ratio

  3. Doses of vasopressors and inotropes

    Time frame: 24 hours post burn injury

    Total doses of vasopressors and inotropes

  4. Doses of vasopressors and inotropes

    Time frame: 48 hours post burn injury

    Total doses of vasopressors and inotropes

  5. Fasciotomy

    Time frame: during the first 48 hours post burn injury

    Documentation of fasciotomy performed

  6. abdominal compartment syndrome

    Time frame: during the first 48 hours post burn injury

    Occurrence of abdominal compartment syndrome

  7. completion of resuscitation

    Time frame: up to 48 hours post burn injury

    Time to completion of resuscitation

  8. AKIN Score (acute kidney injury network)

    Time frame: 24 hours post burn injury

    Acute Kidney Injury Network stage

  9. AKIN Score

    Time frame: 48 hours post burn injury

    Acute Kidney Injury Network stage

  10. AKIN Score

    Time frame: 72 hours post burn injury

    Acute Kidney Injury Network stage

  11. AKIN Score

    Time frame: 96 hours post burn injury

    Acute Kidney Injury Network stage

  12. SOFA score (sequential organ failure assessment)

    Time frame: 24 hours post burn injury

    Sequential Organ Failure Assessment

  13. SOFA score

    Time frame: 48 hours post burn injury

    Sequential Organ Failure Assessment

  14. SOFA score

    Time frame: 72 hours post burn injury

    Sequential Organ Failure Assessment

  15. SOFA score

    Time frame: 96 hours post burn injury

    Sequential Organ Failure Assessment

  16. Mechanical Ventilation

    Time frame: 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

  17. Hospital Stay

    Time frame: from date of hospital admit until date of hospital discharge, assessed over duration of hospitalization up to 12 months

    Length of hospital stay

  18. Survival

    Time frame: 28 days post burn injury or death, whichever occurs first

    In hospital and 28 day survival

Sponsors and collaborators

Lead sponsor

American Burn Association

Other

Collaborators

  • U.S. Army Medical Research Acquisition Activity
  • University of California, Davis

Registry information

Acronym: ABRUPT

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
May 8, 2017
Registry last updated
Jul 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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