Hypoalbuminemia in Burn Patients (Halburns)
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).
Second or Third Degree Burns
Drug: 5% human albumin solution (HAS)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Hypoalbuminemia in Burn Patients: Should we Care? - A Randomized Controlled Clinical Pilot Trial|
- 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). [ Time Frame: Seven days ] [ Designated as safety issue: No ]
- ICU and hospital mortality [ Time Frame: 1, 3 and 6 months ] [ Designated as safety issue: No ]
- ICU and hospital length of stay [ Time Frame: 1, 3 and 6 months ] [ Designated as safety issue: No ]
- Free days of mechanical ventilation [ Time Frame: Seven days ] [ Designated as safety issue: No ]
- Caloric intake [ Time Frame: Seven days ] [ Designated as safety issue: No ]
- Fluid balance [ Time Frame: Seven days ] [ Designated as safety issue: No ]
- Incidence of infection [ Time Frame: Seven days ] [ Designated as safety issue: No ]
- Time to complete coverage defined as the time between admission and last surgery for grafting [ Time Frame: 1, 3 and 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||September 2011|
|Estimated Study Completion Date:||October 2015|
|Estimated Primary Completion Date:||September 2015 (Final data collection date for primary outcome measure)|
Patient will receive 5% HAS daily for the first 7 days of stay in ICU according to their albumin level
Drug: 5% human albumin solution (HAS)
Patient will receive 5% HAS daily for the first 7 days of stay in ICU according to their albumin level:
≥ 30 gr/L: albumin will not be administered; 25 - 29.9 gr/L: 25 g of 5% HAS; 20 - 24.9 gr/L: 50 g 5% HAS; 15 - 19.9 gr/L: 75 g of 5% HAS; 10 - 14.9 gr/L: 100 g of 5% HAS; < 10 gr/L: 150 g of 5% HAS.
Each year approximately 2 million people are burned in the USA, from which 80,000 are hospitalized and 6,500 die. It is a well known fact that the two most important factors for mortality in burn patients are age and percent total body surface area burn (TBSA), which are unmodifiable findings.
A predictable inflammatory response takes place after a burn injury leading to profound changes in patient homeostasis. As a result, hypoalbuminemia is one of the common finding in severe burn patients. 21% of hospitalized adult patients are hypoalbuminemic on admission. After admission, worsening of existing hypoalbuminemia and development of de novo one are frequently seen.
Moreover, hypoalbuminemia, a potentially modifiable variable, has been strongly associated with poor clinical outcomes in critically ill patients and in burn patients.
Dynamic organ dysfunction scores have been introduced in critically ill patients few years ago in order to describe the evolution of patients on a daily basis. The Sequential Organ Failure Assessment (SOFA) score is now one of the most accepted score in critically ill patients and has been validated in general medico-surgical unit, as well as in trauma and cardiac surgery patients. It encompasses components assessing six organ functions. This score has also been shown to predict mortality in critically ill patients and in burn patients when used in a dynamic way.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01436292
|Contact: Roberto Eljaiek, MD||514 890-8000 ext email@example.com|
|Centre hospitalier de l'Université de Montréal (CHUM)||Not yet recruiting|
|Montréal, Quebec, Canada, H2W 1T8|
|Contact: Roberto Eljaiek, MD 514 890-8000 ext 15875 firstname.lastname@example.org|
|Contact: Marc-Jacques Dubois, MD - FRCPC 514 890-8000 ext 15875 email@example.com|
|Principal Investigator:||Roberto Eljaiek, MD||Université de Montréal - CHUM|
|Principal Investigator:||Marc-Jacques Dubois, MD - FRCPC||Université de Montréal - CHUM|