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Hypoalbuminemia in Burn Patients

Information source: Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Second or Third Degree Burns

Intervention: 5% human albumin solution (HAS) (Drug)

Phase: Phase 4

Status: Not yet recruiting

Sponsored by: Centre hospitalier de l'Université de Montréal (CHUM)

Official(s) and/or principal investigator(s):
Roberto Eljaiek, MD, Principal Investigator, Affiliation: Université de Montréal - CHUM
Marc-Jacques Dubois, MD - FRCPC, Principal Investigator, Affiliation: Université de Montréal - CHUM

Overall contact:
Roberto Eljaiek, MD, Phone: 514 890-8000, Ext: 15875, Email: roberto.eljaiek@umontreal.ca

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).

Clinical Details

Official title: Hypoalbuminemia in Burn Patients: Should we Care? - A Randomized Controlled Clinical Pilot Trial

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: 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).

Secondary outcome:

ICU and hospital mortality

ICU and hospital length of stay

Free days of mechanical ventilation

Caloric intake

Fluid balance

Incidence of infection

Time to complete coverage defined as the time between admission and last surgery for grafting

Detailed description: 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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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. -

Locations and Contacts

Roberto Eljaiek, MD, Phone: 514 890-8000, Ext: 15875, Email: roberto.eljaiek@umontreal.ca

Centre hospitalier de l'Université de Montréal (CHUM), Montréal, Quebec H2W 1T8, Canada; Not yet recruiting
Roberto Eljaiek, MD, Phone: 514 890-8000, Ext: 15875, Email: roberto.eljaiek@umontreal.ca
Marc-Jacques Dubois, MD - FRCPC, Phone: 514 890-8000, Ext: 15875, Email: marc-jacques.dubois.chum@ssss.gouv.qc.ca
Additional Information

Starting date: September 2011
Last updated: September 16, 2011

Page last updated: August 23, 2015

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