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)
1 other identifier
interventional
1,100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jul 2002
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 28, 2005
CompletedFirst Posted
Study publicly available on registry
September 29, 2005
CompletedNovember 27, 2013
September 1, 2005
1.1 years
September 28, 2005
November 25, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Patients receiving 4% Albumin will have less incidence and reduced severity of pressure injuries.
Secondary Outcomes (2)
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.
Interventions
Eligibility Criteria
You may qualify if:
- Randomisation to the SAFE study -
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayside Healthlead
Study Sites (1)
The Alfred Hospital, Prahran,
Melbourne, Victoria, 3181, Australia
Related Publications (6)
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.
PMID: 10964183BACKGROUNDHanan 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.
PMID: 2018614BACKGROUNDCullum 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.
PMID: 1578064BACKGROUNDGoodrich 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.
PMID: 1568151BACKGROUNDPeerless 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.
PMID: 10386267BACKGROUNDKuhn MM. Colloids vs crystalloids. Crit Care Nurse. 1991 May;11(5):37-44, 46-51.
PMID: 2026044BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shena M Graham, BN
The Alfred Hospital, Prahran, Melbourne, Australia
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 28, 2005
First Posted
September 29, 2005
Study Start
July 1, 2002
Primary Completion
August 1, 2003
Study Completion
August 1, 2003
Last Updated
November 27, 2013
Record last verified: 2005-09