Hypoalbuminemia in Burn Patients

NCT01436292 | Withdrawn Phase 4 DMC

• 1 other identifier: CE 10.239
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

Second or Third Degree Burns

Keywords

Hypoalbuminemia; Burns; Albumin; Organ dysfunction; Outcome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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

Study Arms (1)

Albumin

EXPERIMENTAL

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)

Interventions

5% human albumin solution (HAS) DRUG

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.

Albumin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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. -

You may not qualify if:

• 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. -

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead
• Centre de Recherche du Centre Hospitalier de l'Université de Montréal: collaborator

Study Sites (1)

Centre hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, H2W 1T8, Canada

Location

MeSH Terms

Conditions

Neoplasm Metastasis; Hypoalbuminemia; Burns

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hypoproteinemia; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Wounds and Injuries

Study Officials

• Roberto Eljaiek, MD

  Université de Montréal - CHUM

  PRINCIPAL INVESTIGATOR

• Marc-Jacques Dubois, MD - FRCPC

  Université de Montréal - CHUM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2011
• First Posted: September 19, 2011
• Study Start: September 1, 2011
• Primary Completion: September 1, 2015
• Study Completion: October 1, 2015
• Last Updated: November 17, 2022

Record last verified: 2022-11

Locations

CA (1)