Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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%)

Study Design

Phase
N/A
Study Type
Interventional
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.
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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 names:
    • albumin

Recruiting Locations

University of Kansas Health System
Kansas City, Kansas 66160
Contact:
Jessica Reynolds
jreynolds11@kumc.edu

More Details

Status
Recruiting
Sponsor
American Burn Association

Study Contact

Katrina Falwell, RN, BSN
916-453-2134
kafalwell@ucdavis.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.