Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2025-12-30 @ 2:59 AM
Study NCT ID:
NCT00228657
Status:
COMPLETED
Last Update Posted:
2013-11-27
First Post:
2005-09-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Formation and Severity of Pressure Ulcers Associated With 4% Albumin vs. 0.9% Sodium Chloride
Sponsor:
Bayside Health
Organization:
Study Overview
Official Title:
The Formation and Severity of Pressure Ulcers Associated With 4% Albumin vs. 0.9% Sodium Chloride Administration (Substudy of SAFE Protocol 153711)
Status:
COMPLETED
Status Verified Date:
2005-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: