Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00179192
Status:
WITHDRAWN
Last Update Posted:
2015-05-25
First Post:
2005-09-13
Brief Title:
Prevention and Treatment of Hemodialysis Vascular Access Malfunction
Sponsor:
Vanderbilt University
Organization:
Vanderbilt University
Study Overview
Official Title:
Prevention and Treatment of Hemodialysis Vascular Access Malfunction
Status:
WITHDRAWN
Status Verified Date:
2015-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
non-enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Vascular access is considered the Achilles heel of the dialysis patient It constitutes the largest single cause of morbidity in the chronic hemodialysis population accounting for over 25 of hospitalizations at an estimated cost in the US of at least one billion dollars annually Currently complication free survival of vascular access ranges between 30-50 a year and multiple investigative efforts in this area have been initiated and are directed at prolonging the functional life of vascular accesses
It is not well established whether intervention prior to overt malfunction or thrombosis of the vascular access could reduce these complications and thereby improve the functional longevity of the access Moreover once accesses at potential risk are identified it is not well established which method of intervention Surgery vs Angioplasty vs Expectant Management is superior in terms of clinical and financial outcome The proposed study aims to determine whether early intervention of a vascular access determined to be at risk of malfunction and thrombosis improves the long term outcome and specifically which means of intervention is preferred
It is not well established whether intervention prior to overt malfunction or thrombosis of the vascular access could reduce these complications and thereby improve the functional longevity of the access Moreover once accesses at potential risk are identified it is not well established which method of intervention Surgery vs Angioplasty vs Expectant Management is superior in terms of clinical and financial outcome The proposed study aims to determine whether early intervention of a vascular access determined to be at risk of malfunction and thrombosis improves the long term outcome and specifically which means of intervention is preferred
Detailed Description:
None
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