Back to resultsFormation and Severity of Pressure Ulcers Associated With 4% Albumin vs. 0.9% Sodium Chloride
Primary Purpose
Pressure Ulcer, Area, Pressure Ulcer, Grade, Albumin Level
Status
Completed
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
4% Albumin / 0.9% Sodium Chloride
Sponsored by
About this trial
This is an interventional diagnostic trial for Pressure Ulcer, Area
Eligibility 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-
Sites / Locations
- The Alfred Hospital, Prahran,
Outcomes
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00228657
Brief Title
Formation and Severity of Pressure Ulcers Associated With 4% Albumin vs. 0.9% Sodium Chloride
Official Title
The Formation and Severity of Pressure Ulcers Associated With 4% Albumin vs. 0.9% Sodium Chloride Administration (Substudy of SAFE Protocol 153711)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
July 2002 (undefined)
Primary Completion Date
August 2003 (Actual)
Study Completion Date
August 2003 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayside Health
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pressure Ulcer, Area, Pressure Ulcer, Grade, Albumin Level, Risk Score, Length of ICU Stay
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
1100 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
4% Albumin / 0.9% Sodium Chloride
Primary Outcome Measure Information:
Title
Patients receiving 4% Albumin will have less incidence and reduced severity of pressure injuries.
Secondary Outcome Measure Information:
Title
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
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shena M Graham, BN
Organizational Affiliation
The Alfred Hospital, Prahran, Melbourne, Australia
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Alfred Hospital, Prahran,
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3181
Country
Australia
12. IPD Sharing Statement
Citations:
PubMed Identifier
10964183
Citation
Anthony D, Reynolds T, Russell L. An investigation into the use of serum albumin in pressure sore prediction. J Adv Nurs. 2000 Aug;32(2):359-65. doi: 10.1046/j.1365-2648.2000.01484.x.
Results Reference
background
PubMed Identifier
2018614
Citation
Hanan K, Scheele L. Albumin vs. weight as a predictor of nutritional status and pressure ulcer development. Ostomy Wound Manage. 1991 Mar-Apr;33:22-7. No abstract available.
Results Reference
background
PubMed Identifier
1578064
Citation
Cullum N, Clark M. Intrinsic factors associated with pressure sores in elderly people. J Adv Nurs. 1992 Apr;17(4):427-31. doi: 10.1111/j.1365-2648.1992.tb01926.x.
Results Reference
background
PubMed Identifier
1568151
Citation
Goodrich C, March K. From ED to ICU: a focus on prevention of skin breakdown. Crit Care Nurs Q. 1992 May;15(1):1-13. doi: 10.1097/00002727-199205000-00002. No abstract available.
Results Reference
background
PubMed Identifier
10386267
Citation
Peerless JR, Davies A, Klein D, Yu D. Skin complications in the intensive care unit. Clin Chest Med. 1999 Jun;20(2):453-67, x. doi: 10.1016/s0272-5231(05)70152-0.
Results Reference
background
PubMed Identifier
2026044
Citation
Kuhn MM. Colloids vs crystalloids. Crit Care Nurse. 1991 May;11(5):37-44, 46-51.
Results Reference
background
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Formation and Severity of Pressure Ulcers Associated With 4% Albumin vs. 0.9% Sodium Chloride
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