An interventional study of Albumin Human in Burn Injury, sponsored by American Burn Association. Completed at 26 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-20.
Sponsored by American Burn Association · Not applicable, Interventional, and Treatment
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.
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.
719 studies on the registry are indexed under Burns; 145 are open to participants now.
This study's enrollment of 101 is above the median of 40 across 524 interventional studies indexed under Burns.
Browse Burns studies →American Burn Association is the lead sponsor of 9 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
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
Also known as: albumin
Volume of fluid received during resuscitation for burn injury
Total fluid resuscitation volume at 24 hours post burn in mL/kg/% TBSA burn
Time frame: 24 hours post burn injury
Volume of fluid received during resuscitation for burn injury
Total resuscitation volume at 48 hours in mL/kg/%TBSA burn.
Time frame: 48 hours post burn injury
Urine output during resuscitation for burn injury
Mean hourly urine output during resuscitation for burn injury
Time frame: 24 and 48 hours post burn injury
Number of crossovers
Number of crossovers between study arms during resuscitation for burn injury
Time frame: 48 hours post burn injury
Peak lactate and delta lactate
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 intra-abdominal pressure (IAP) and delta IAP (peak IAP minus admission IAP)
Time frame: 48 hours post burn injury
Occurrence of Abdominal compartment syndrome
Abdominal compartment syndrome during resuscitation for burn injury
Time frame: 48 hours post burn injury
Occurrence of Limb or abdominal fasciotomy
Limb or abdominal fasciotomy during resuscitation for burn injury
Time frame: 48 hours post burn injury
Sequential Organ Failure Assessment (SOFA) score
Assessment of organ function or failure by Sequential Organ Failure Assessment (SOFA)score, with the higher score(s) indicating organ failure
Time frame: 48, 72, and 96 hours post burn injury
Acute kidney injury (AKI)
Diagnosis of AKI
Time frame: 96 hours post burn injury
Duration of intubation/mechanical ventilation
Duration of intubation/mechanical ventilation
Time frame: 96 hours post burn injury
PaO2/FiO2 ratios
PaO2(partial pressure of oxygen)/FiO2(fraction of inspired oxygen inspired oxygen) ratios
Time frame: 24, 48, 72, and 96 hours post burn injury
Time to wound healing
Time to wound healing defined as 7 days post last grafting surgery
Time frame: 7 days post last surgery for grafting of burn injury
Survival
28 day survival and hospital stay survival
Time frame: 28 days post injury and hospital discharge
Plan to share: No
This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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American Burn Association