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

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.

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.

Official Title

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

Conditions

Study Type

Interventional

Study Design

Diagnostic, Randomized, Double-Blind, Dose Comparison, Parallel Assignment

Further Details

Primary Outcome Measures: 
Patients receiving 4% Albumin will have less incidence and reduced severity of pressure injuries.

Secondary Outcome Measures: 
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.

Study Start

Study start: July 2002; Study completion: June 2003

Eligibility & Criteria

• Ages Eligible for Study: 18 Years and above
• Genders Eligible for Study:  Both

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.

Total Enrolment

1100

Contact Details

Shena M Graham, BN, Principal Investigator, The Alfred Hospital, Prahran, Melbourne, Australia.