Ignite Creation Date:
2025-12-17 @ 8:07 PM
Ignite Modification Date:
2025-12-23 @ 10:31 PM
Study NCT ID:
NCT00736827
Status:
None
Last Update Posted:
2015-12-04 00:00:00
First Post:
2008-08-15 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
BK Virus and Renal Dysfunction in Postoperative/Posttraumatic Critically Ill Patients
Sponsor:
None
Organization:
Study Overview
Official Title:
BK Virus and Renal Dysfunction in Postoperative/Posttraumatic Critically Ill Patients
Status:
None
Status Verified Date:
2015-12
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:
BICUK
Brief Summary:
Polyomavirus BK virus (BKV) infection and nephropathy is a significant cause of allograft dysfunction in kidney transplantation. Clinical manifestation ranges from BK viremia and nephritis to renal dysfunction. It has been suggested that BK virus reactivation alone is not sufficient to cause BK viremia and nephropathy, thus a second hit is essential for kidney specific damage, such as an inflammatory reaction or ischemia. Critically ill postoperative/posttraumatic patients via the systemic inflammatory response syndrome (SIRS) and the compensatory antiinflammatory response syndrome (CARS) are at increased risk to develop organ dysfunctions, such as acute renal failure. CARS, reflecting postoperative/posttraumatic immunosuppression, may favor viral reactivation. However, prevalence of BK viremia in critically ill postoperative/posttraumatic patients has up to now not been systematically evaluated. Moreover, it is not known whether BK viremia is associated with a distinct biomarker pattern in these patients. Therefore, the present study is performed to clarify whether postoperative/posttraumatic immunosuppression is associated with BK viremia, and acute renal failure with BK virus reactivation, respectively.
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?: