Formation and Severity of Pressure Ulcers Associated With 4% Albumin vs. 0.9% Sodium Chloride

Phase 1

Completed

• Conditions: Pressure Ulcer, Area; Pressure Ulcer, Grade; Albumin Level; Risk Score; Length of ICU Stay

• Registration Number: NCT00228657
• Lead Sponsor: Bayside Health

Brief Summary

Patients resuscitated with 4% Albumin will have less incidence and reduced severity of pressure injuries than patients resuscitated with 0.9% Sodium Chloride due to the improved intravascular oncotic pressure effected from higher albumin levels.

Detailed Description

Pressure ulcers incur multiple risks to the patient. The disruption of the skin is a portal of entry for infection , which may remain localised to the site or become blood borne. A pressure ulcer can lead to protein and fluid losses from the wound exudate. Many authors have theorised the existence of a relationship between the development of pressure ulcers and low serum albumin levels however, there is no strong evidence to prove this correlation. The literature does demonstrate a clear relationship between people with existing pressure ulcers and the presence of low serum albumins. Specifically serum albumin levels \<30mg/dl have been associated with the incidence of pressure ulcer development.

Study Timeline

• Study Start: 2002-07
• Primary Completion: 2003-08
• Study Completion: 2003-08
• Status Verified: 2005-09
• Study First Submitted: 2005-09-28
• Study First Submitted QC: 2005-09-28
• Study First Posted: 2005-09-29
• Last Update Submitted: 2013-11-25
• Last Update Posted: 2013-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1100

Inclusion Criteria

Randomisation to the SAFE study -

Exclusion Criteria

In addition to the SAFE exclusion criteria, pre-existing pressure ulcers (developed prior to ICU admission) will also be excluded-

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Patients receiving 4% Albumin will have less incidence and reduced severity of pressure injuries.

Secondary Outcome Measures

Name	Time	Method
Is there a difference in the incidence of pressure injuries between those patients resuscitated with 4% Albumin and patients resuscitated with 0.9% Sodium Chloride
Is there a difference in the severity of pressure injuries between those patients resuscitated with 4% Albumin and patients resuscitated with 0.9% Sodium Chloride.

Trial Locations

Locations (1)

The Alfred Hospital, Prahran,; 🇦🇺 Melbourne, Victoria, Australia