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

This study has been completed.

Sponsor:

Collaborator:

University of Wuerzburg

Information provided by (Responsible Party):

Manfred Weiss, University of Ulm

ClinicalTrials.gov Identifier:

NCT00736827

First received: August 15, 2008

Last updated: February 5, 2013

Last verified: February 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

August 15, 2008

Last Updated Date

February 5, 2013

Start Date ^ICMJE

August 2008

Primary Completion Date

August 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Association between BK virus reactivation and acute renal dysfunction [ Time Frame: 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. ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00736827 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Pattern of biomarkers and surface markers on leukocytes. [ Time Frame: First day of acute renal dysfunction, first days on hemodiafiltration, first day after hemodiafiltration, before demission from intensive care unit or death. ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

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 Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Retention: Samples With DNA

Description:

Whole blood, serum, white blood cells; urine

Sampling Method

Probability Sample

Study Population

Postoperative/posttraumatic critically ill patients admitted to the intensive care unit

Condition ^ICMJE

Acute Renal Failure
SIRS
Sepsis
Critically Ill
Multiple Organ Dysfunction Syndrome

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Postoperative/posttraumatic surgical critically ill patients with septic or haemorrhagic shock with threatening acute renal failure

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2012

Primary Completion Date

August 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Critically ill, postoperative/posttraumatic patients with threatening acute renal failure

Exclusion Criteria:

Life expectancy < 24 hours
Participation in other trials
Known or suspected pregnancy

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT00736827

Other Study ID Numbers ^ICMJE

Anae_ICU_Ulm_BKV

Has Data Monitoring Committee

Responsible Party

Manfred Weiss, University of Ulm

Study Sponsor ^ICMJE

University of Ulm

Collaborators ^ICMJE

University of Wuerzburg

Investigators ^ICMJE

Principal Investigator:

Manfred Weiss, MD, MBA

University Hospital Ulm

Information Provided By

University of Ulm

Verification Date

February 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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