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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayside Health
ClinicalTrials.gov Identifier:
NCT00228657
First received: September 28, 2005
Last updated: November 25, 2013
Last verified: September 2005
  Purpose

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.


Condition Intervention Phase
Pressure Ulcer, Area
Pressure Ulcer, Grade
Albumin Level
Risk Score
Length of ICU Stay
Drug: 4% Albumin / 0.9% Sodium Chloride
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Diagnostic
Official Title: The Formation and Severity of Pressure Ulcers Associated With 4% Albumin vs. 0.9% Sodium Chloride Administration (Substudy of SAFE Protocol 153711)

Resource links provided by NLM:


Further study details as provided by Bayside Health:

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.

Estimated Enrollment: 1100
Study Start Date: July 2002
Study Completion Date: August 2003
Primary Completion Date: August 2003 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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-

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00228657

Locations
Australia, Victoria
The Alfred Hospital, Prahran,
Melbourne, Victoria, Australia, 3181
Sponsors and Collaborators
Bayside Health
Investigators
Principal Investigator: Shena M Graham, BN The Alfred Hospital, Prahran, Melbourne, Australia
  More Information

Publications:
Responsible Party: Bayside Health
ClinicalTrials.gov Identifier: NCT00228657     History of Changes
Other Study ID Numbers: 137/99
Study First Received: September 28, 2005
Last Updated: November 25, 2013
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Additional relevant MeSH terms:
Pressure Ulcer
Ulcer
Pathologic Processes
Skin Diseases
Skin Ulcer

ClinicalTrials.gov processed this record on October 29, 2014