WithdrawnPhase 4

Hypoalbuminemia in Burn Patients

Stopped: No funding

Canada0Started 2011-09

Plain-language summary

The purpose of this study is to determine whether 5% human albumin solution, given to correct hypoalbuminemia, could improve organ dysfunction in burn patients as assessed by a change in the SOFA score from baseline to day 7 (or before if the patient is discharged from the ICU or died).

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Patients admitted to the BICU in the Centre hospitalier de l'Université de Montréal within 24 hours following their thermal burn injury.
✓. Patients with second or third degree burns greater or equal than 20% of total body surface area.
✓. Patients aged 18 years or older. -

Exclusion criteria

✕. Patients with serum albumin greater than 30 g/dl at the time of randomization.
✕. Patients with a do not resuscitate order.
✕. Patients needing total parenteral nutrition.
✕. Patients with the following chronic diseases that could affect baseline SOFA calculation or serum albumin levels: end-stage kidney disease, nephrotic syndrome, hepatitis, exudative enteropaty, chronic thrombocytopenia or hematological malignancy.
✕. Patients with a known reaction to albumin.
✕. Pregnant or lactating women.
✕. Patients younger than 18 years old. -

What they're measuring

Organ dysfunction as assessed by a change in the SOFA score from baseline to day 7 (or before if the patient is discharged from the ICU or died).

Timeframe: Seven days

Trial details

NCT IDNCT01436292

SponsorCentre hospitalier de l'Université de Montréal (CHUM)

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-09

View on ClinicalTrials.gov More Second or Third Degree Burns trials