Albumin Human
DrugAddition of albumin during acute resuscitation following burn injury
Other names: albumin
NCT Number: NCT04356859
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
University of Alberta, Edmonton, Alberta, Canada
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Addition of albumin during acute resuscitation following burn injury
Other names: albumin
Time frame: 24 hours post burn injury
Total fluid resuscitation volume at 24 hours post burn in mL/kg/% TBSA burn
Time frame: 48 hours post burn injury
Total resuscitation volume at 48 hours in mL/kg/%TBSA burn.
Time frame: 24 and 48 hours post burn injury
Mean hourly urine output during resuscitation for burn injury
Time frame: 48 hours post burn injury
Number of crossovers between study arms during resuscitation for burn injury
Time frame: 48 hours post burn injury
peak lactate level and delta lactate (peak lactate minus admission lactate)
Time frame: 48 hours post burn injury
Peak intra-abdominal pressure (IAP) and delta IAP (peak IAP minus admission IAP)
Time frame: 48 hours post burn injury
Abdominal compartment syndrome during resuscitation for burn injury
Time frame: 48 hours post burn injury
Limb or abdominal fasciotomy during resuscitation for burn injury
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
Time frame: 96 hours post burn injury
Diagnosis of AKI
Time frame: 96 hours post burn injury
Duration of intubation/mechanical ventilation
Time frame: 24, 48, 72, and 96 hours post burn injury
PaO2(partial pressure of oxygen)/FiO2(fraction of inspired oxygen inspired oxygen) ratios
Time frame: 7 days post last surgery for grafting of burn injury
Time to wound healing defined as 7 days post last grafting surgery
Time frame: 28 days post injury and hospital discharge
28 day survival and hospital stay survival
American Burn Association
Other
The Acute Burn ResUscitation Multicenter Prospective Trial (ABRUPT2)
Acronym: ABRUPT2
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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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