Clinical trial · Interventional
Hypoalbuminemia in Burn Patients
Hypoalbuminemia in Burn Patients: Should we Care? - A Randomized Controlled Clinical Pilot Trial
NCT01436292CI-TRIAL-00062237HalburnswithdrawnPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): No funding
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Second or Third Degree Burns | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5% human albumin solution (HAS) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Albumin
- description
- Patient will receive 5% HAS daily for the first 7 days of stay in ICU according to their albumin level
- interventionNames
- Drug: 5% human albumin solution (HAS)
Primary outcomes (1)
- measure
- 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
Secondary outcomes (7)
- measure
- ICU and hospital mortality
- timeFrame
- 1, 3 and 6 months
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients admitted to the BICU in the Centre hospitalier de l'Université de Montréal within 24 hours following their thermal burn injury. 2. Patients with second or third degree burns greater or equal than 20% of total body surface area. 3. Patients aged 18 years or older. - Exclusion Criteria: 1. Patients with serum albumin greater than 30 g/dl at the time of randomization. 2. Patients with a do not resuscitate order. 3. Patients needing total parenteral nutrition. 4. 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. 5. Patients with a known reaction to albumin. 6. Pregnant or lactating women. 7. Patients younger than 18 years old. -
References
Publications (0)
Data not yet available
No reference posted for this study.