Hypoalbuminemia in Burn Patients (Halburns)

This study is not yet open for participant recruitment.
Verified September 2011 by Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor:
Collaborator:
Centre de Recherche du Centre Hospitalier de l'Université de Montréal
Information provided by (Responsible Party):
Marc-Jacques Dubois, Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier:
NCT01436292
First received: July 14, 2011
Last updated: September 16, 2011
Last verified: September 2011
  Purpose

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).


Condition Intervention Phase
Second or Third Degree Burns
Drug: 5% human albumin solution (HAS)
Phase 4

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Centre hospitalier de l'Université de Montréal (CHUM):

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 128
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)
Arms Assigned Interventions
Experimental: Albumin
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.


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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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. -
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01436292

Contacts
Contact: Roberto Eljaiek, MD 514 890-8000 ext 15875 roberto.eljaiek@umontreal.ca

Locations
Canada, Quebec
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    roberto.eljaiek@umontreal.ca   
Contact: Marc-Jacques Dubois, MD - FRCPC    514 890-8000 ext 15875    marc-jacques.dubois.chum@ssss.gouv.qc.ca   
Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
Centre de Recherche du Centre Hospitalier de l'Université de Montréal
Investigators
Principal Investigator: Roberto Eljaiek, MD Université de Montréal - CHUM
Principal Investigator: Marc-Jacques Dubois, MD - FRCPC Université de Montréal - CHUM
  More Information

No publications provided

Responsible Party: Marc-Jacques Dubois, MD, FRCPC, Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier: NCT01436292     History of Changes
Other Study ID Numbers: CE 10.239
Study First Received: July 14, 2011
Last Updated: September 16, 2011
Health Authority: Canada: Ethics Review Committee

Keywords provided by Centre hospitalier de l'Université de Montréal (CHUM):
Hypoalbuminemia
Burns
Albumin
Organ dysfunction
Outcome

Additional relevant MeSH terms:
Burns
Hypoalbuminemia
Wounds and Injuries
Hypoproteinemia
Blood Protein Disorders
Hematologic Diseases

ClinicalTrials.gov processed this record on April 17, 2014