Hypoalbuminemia in Burn Patients (Halburns)

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

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).

Study Overview

• Status: Withdrawn
• Conditions: Second or Third Degree Burns
• Intervention / Treatment: Drug: 5% human albumin solution (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.

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H2W 1T8
      • Centre hospitalier de l'Universite de Montreal (CHUM)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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. -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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).	Seven days

Secondary Outcome Measures

Outcome Measure	Time Frame
ICU and hospital mortality	1, 3 and 6 months
ICU and hospital length of stay	1, 3 and 6 months
Free days of mechanical ventilation	Seven days
Caloric intake	Seven days
Fluid balance	Seven days
Incidence of infection	Seven days
Time to complete coverage defined as the time between admission and last surgery for grafting	1, 3 and 6 months

Collaborators and Investigators

• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
• Collaborators: 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

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Anticipated): September 1, 2015
• Study Completion (Anticipated): October 1, 2015

Study Registration Dates

• First Submitted: July 14, 2011
• First Submitted That Met QC Criteria: September 16, 2011
• First Posted (Estimate): September 19, 2011

Study Record Updates

• Last Update Posted (Actual): November 17, 2022
• Last Update Submitted That Met QC Criteria: November 15, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Outcome; Burns; Organ dysfunction; Albumin; Hypoalbuminemia
• Additional Relevant MeSH Terms: Wounds and Injuries; Hematologic Diseases; Blood Protein Disorders; Hypoproteinemia; Burns; Hypoalbuminemia
• Other Study ID Numbers: CE 10.239