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The Acute Burn ResUscitation Multicenter Prospective Trial (ABRUPT2)

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ClinicalTrials.gov Identifier: NCT04356859
Recruitment Status : Recruiting
First Posted : April 22, 2020
Last Update Posted : August 11, 2022
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
American Burn Association

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Burn Injury Drug: Albumin Human Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: The Acute Burn ResUscitation Multicenter Prospective Trial (ABRUPT2)
Actual Study Start Date : April 22, 2021
Estimated Primary Completion Date : March 2024
Estimated Study Completion Date : September 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns

Arm Intervention/treatment
No Intervention: Crystalloid
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
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
Addition of albumin during acute resuscitation following burn injury
Other Name: albumin




Primary Outcome Measures :
  1. Volume of fluid received during resuscitation for burn injury [ Time Frame: 24 hours post burn injury ]
    Total fluid resuscitation volume at 24 hours post burn in mL/kg/% TBSA burn


Secondary Outcome Measures :
  1. Volume of fluid received during resuscitation for burn injury [ Time Frame: 48 hours post burn injury ]
    Total resuscitation volume at 48 hours in mL/kg/%TBSA burn.

  2. Urine output during resuscitation for burn injury [ Time Frame: 24 and 48 hours post burn injury ]
    Mean hourly urine output during resuscitation for burn injury

  3. Number of crossovers [ Time Frame: 48 hours post burn injury ]
    Number of crossovers between study arms during resuscitation for burn injury

  4. Peak lactate and delta lactate [ Time Frame: 48 hours post burn injury ]
    peak lactate level and delta lactate (peak lactate minus admission lactate)

  5. Peak intra-abdominal pressure (IAP) and delta IAP [ Time Frame: 48 hours post burn injury ]
    Peak intra-abdominal pressure (IAP) and delta IAP (peak IAP minus admission IAP)

  6. Occurrence of Abdominal compartment syndrome [ Time Frame: 48 hours post burn injury ]
    Abdominal compartment syndrome during resuscitation for burn injury

  7. Occurrence of Limb or abdominal fasciotomy [ Time Frame: 48 hours post burn injury ]
    Limb or abdominal fasciotomy during resuscitation for burn injury

  8. Sequential Organ Failure Assessment (SOFA) score [ Time Frame: 48, 72, and 96 hours post burn injury ]
    Assessment of organ function or failure by Sequential Organ Failure Assessment (SOFA)score, with the higher score(s) indicating organ failure

  9. Acute kidney injury (AKI) [ Time Frame: 96 hours post burn injury ]
    Diagnosis of AKI

  10. Duration of intubation/mechanical ventilation [ Time Frame: 96 hours post burn injury ]
    Duration of intubation/mechanical ventilation

  11. PaO2/FiO2 ratios [ Time Frame: 24, 48, 72, and 96 hours post burn injury ]
    PaO2(partial pressure of oxygen)/FiO2(fraction of inspired oxygen inspired oxygen) ratios

  12. Time to wound healing [ Time Frame: 7 days post last surgery for grafting of burn injury ]
    Time to wound healing defined as 7 days post last grafting surgery

  13. Survival [ Time Frame: 28 days post injury and hospital discharge ]
    28 day survival and hospital stay 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
Criteria

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%)

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): NCT04356859


Contacts
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Contact: Katrina Falwell, RN, BSN 916-453-2134 kafalwell@ucdavis.edu
Contact: Mary Beth Lawless, RN, MS 916-453-2132 mblawless@ucdavis.edu

Locations
Show Show 26 study locations
Sponsors and Collaborators
American Burn Association
United States Department of Defense
Investigators
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Principal Investigator: David G Greenhalgh, MD UC Davis Health
Publications:
Mehrkens HH, Ahnefeld FW. Volume and fluid replacement in the early post burn period: an animal experimental study. Burns 1979;5:113-15

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Responsible Party: American Burn Association
ClinicalTrials.gov Identifier: NCT04356859    
Other Study ID Numbers: 1528946
CDMRP-JW180038 ( Other Grant/Funding Number: US Army Department of Defense CDMRP )
First Posted: April 22, 2020    Key Record Dates
Last Update Posted: August 11, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by American Burn Association:
Resuscitation
Additional relevant MeSH terms:
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Burns
Wounds and Injuries