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The Acute Burn Resuscitation Multicenter Prospective Observational Trial (ABRUPT)

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ClinicalTrials.gov Identifier: NCT03144427
Recruitment Status : Recruiting
First Posted : May 8, 2017
Last Update Posted : June 26, 2018
Sponsor:
Collaborators:
U.S. Army Medical Research Acquisition Activity
University of California, Davis
Information provided by (Responsible Party):
American Burn Association

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.

Condition or disease
Burns Shock

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").

Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Acute Burn Resuscitation Multicenter Prospective Observational Trial
Actual Study Start Date : February 24, 2017
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns

Group/Cohort
Burns
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



Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients must be ≥ 18 years of age with a TBSA burn of ≥ 20%, and they must have been admitted to the burn center ≤ 12 hours following the injury.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03144427


Contacts
Contact: Katrina Falwell, BSN 916-453-2134 kafalwell@ucdavis.edu
Contact: MaryBeth Lawless, MS 916-453-2133 mblawless@ucdavis.edu

Locations
United States, California
University of California Davis Medical Center-Regional Burn Center Recruiting
Sacramento, California, United States, 95817
Contact: Katrina Falwell, BSN    916-453-2134    kafalwell@ucdavis.edu   
Contact: MaryBeth Lawless, MS    916-453-2133    mblawless@ucdavis.edu   
Principal Investigator: David Greenhalgh, MD         
Sponsors and Collaborators
American Burn Association
U.S. Army Medical Research Acquisition Activity
University of California, Davis
Investigators
Principal Investigator: David Greenhalgh, MD University of California, Davis

Publications:
25. Mehrkens HH, Ahnefeld FW. Volume and fluid replacement in the early post burn period: an animal experimental study. Burns 1979;5:113-15

Responsible Party: American Burn Association
ClinicalTrials.gov Identifier: NCT03144427     History of Changes
Other Study ID Numbers: ABuRN-001
W81XWH-16-2-0048 Log#MB150076 ( Other Grant/Funding Number: U.S. Army Medical Research Acquisition Activity )
First Posted: May 8, 2017    Key Record Dates
Last Update Posted: June 26, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by American Burn Association:
albumin
resuscitation
burns
shock
fluid creep

Additional relevant MeSH terms:
Burns
Wounds and Injuries