Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:56 PM
Ignite Modification Date:
2025-12-24 @ 2:56 PM
NCT ID:
NCT04356859
Eligibility 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%)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04356859
Study Brief:
Protocol Section:
NCT04356859