Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00228657
Status:
COMPLETED
Last Update Posted:
2013-11-27
First Post:
2005-09-28
Brief Title:
Formation and Severity of Pressure Ulcers Associated With 4 Albumin vs 09 Sodium Chloride
Sponsor:
Bayside Health
Organization:
Bayside Health
Study Overview
Official Title:
The Formation and Severity of Pressure Ulcers Associated With 4 Albumin vs 09 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 09 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 30mgdl have been associated with the incidence of pressure ulcer development
Study Oversight
Has Oversight DMC:
None
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?:
None