BICUK: BK Virus and Renal Dysfunction in Postoperative/Posttraumatic Critically Ill Patients

Sponsor

University of Ulm (Other)

Overall Status

Completed

CT.gov ID

NCT00736827

Collaborator

University of Wuerzburg (Other)

Enrollment

Location

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to find out whether acute renal failure is associated with BK virus reactivation in postoperative/posttraumatic critically ill patients with severe SIRS/sepsis and shock.

Condition or Disease	Intervention/Treatment	Phase
Acute Renal Failure SIRS Sepsis Critically Ill Multiple Organ Dysfunction Syndrome

Detailed Description

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.

Study Design

Study Type:

Observational

Actual Enrollment :

51 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

BK Virus and Renal Dysfunction in Postoperative/Posttraumatic Critically Ill Patients

Study Start Date :

Aug 1, 2008

Actual Primary Completion Date :

Aug 1, 2012

Actual Study Completion Date :

Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Patients with non-septic shock Postoperative/posttraumatic surgical critically ill patients with non-septic shock with threatening acute renal failure
Patients with septic shock Postoperative/posttraumatic surgical critically ill patients with septic shock with threatening acute renal failure

Outcome Measures

Primary Outcome Measures

Association between BK virus reactivation and acute renal dysfunction [Daily monitoring of acute renal failure, first day of acute renal dysfunction, first days on hemodiafiltration, first day after hemodiafiltration, before demission from intensive care unit or death.]

Secondary Outcome Measures

Pattern of biomarkers and surface markers on leukocytes. [First day of acute renal dysfunction, first days on hemodiafiltration, first day after hemodiafiltration, before demission from intensive care unit or death.]