NCT00228657

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

The Formation and Severity of Pressure Ulcers Associated With 4% Albumin vs. 0.9% Sodium Chloride Administration (Substudy of SAFE Protocol 153711)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 1,100 (planned)
• Sponsor: Bayside Health · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DRUG	4% Albumin / 0.9% Sodium Chloride

Timeline

• Start date: 2002-07-01
• Primary completion: 2003-08-01
• Completion: 2003-08-01
• First posted: 2005-09-29
• Last updated: 2013-11-27

Locations

1 site across 1 country: Australia