Hypoalbuminemia in Burn Patients (Halburns)
Primary Purpose
Second or Third Degree Burns
Status
Withdrawn
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
5% human albumin solution (HAS)
Sponsored by
About this trial
This is an interventional treatment trial for Second or Third Degree Burns focused on measuring Hypoalbuminemia, Burns, Albumin, Organ dysfunction, Outcome
Eligibility Criteria
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. -
Sites / Locations
- Centre hospitalier de l'Université de Montréal (CHUM)
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Albumin
Arm Description
Patient will receive 5% HAS daily for the first 7 days of stay in ICU according to their albumin level
Outcomes
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).
Secondary Outcome Measures
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
Full Information
NCT ID
NCT01436292
First Posted
July 14, 2011
Last Updated
November 15, 2022
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Collaborators
Centre de Recherche du Centre Hospitalier de l'Université de Montréal
1. Study Identification
Unique Protocol Identification Number
NCT01436292
Brief Title
Hypoalbuminemia in Burn Patients
Acronym
Halburns
Official Title
Hypoalbuminemia in Burn Patients: Should we Care? - A Randomized Controlled Clinical Pilot Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Withdrawn
Why Stopped
No funding
Study Start Date
September 2011 (undefined)
Primary Completion Date
September 2015 (Anticipated)
Study Completion Date
October 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Collaborators
Centre de Recherche du Centre Hospitalier de l'Université de Montréal
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Second or Third Degree Burns
Keywords
Hypoalbuminemia, Burns, Albumin, Organ dysfunction, Outcome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Albumin
Arm Type
Experimental
Arm Description
Patient will receive 5% HAS daily for the first 7 days of stay in ICU according to their albumin level
Intervention Type
Drug
Intervention Name(s)
5% human albumin solution (HAS)
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
ICU and hospital mortality
Time Frame
1, 3 and 6 months
Title
ICU and hospital length of stay
Time Frame
1, 3 and 6 months
Title
Free days of mechanical ventilation
Time Frame
Seven days
Title
Caloric intake
Time Frame
Seven days
Title
Fluid balance
Time Frame
Seven days
Title
Incidence of infection
Time Frame
Seven days
Title
Time to complete coverage defined as the time between admission and last surgery for grafting
Time Frame
1, 3 and 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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. -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roberto Eljaiek, MD
Organizational Affiliation
Université de Montréal - CHUM
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marc-Jacques Dubois, MD - FRCPC
Organizational Affiliation
Université de Montréal - CHUM
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre hospitalier de l'Université de Montréal (CHUM)
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2W 1T8
Country
Canada
12. IPD Sharing Statement
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Hypoalbuminemia in Burn Patients
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