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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00736827
Recruitment Status : Completed
First Posted : August 18, 2008
Last Update Posted : December 4, 2015
Sponsor:
Collaborator:
University of Wuerzburg
Information provided by (Responsible Party):
Manfred Weiss, University of Ulm

Tracking Information
First Submitted Date August 15, 2008
First Posted Date August 18, 2008
Last Update Posted Date December 4, 2015
Study Start Date August 2008
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 15, 2008)
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. ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: August 15, 2008)
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. ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title BK Virus and Renal Dysfunction in Postoperative/Posttraumatic Critically Ill Patients
Official Title 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 Observational
Study Design 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
  • Acute Renal Failure
  • SIRS
  • Sepsis
  • Critically Ill
  • Multiple Organ Dysfunction Syndrome
Intervention Not Provided
Study Groups/Cohorts
  • 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
Publications * Nass M, Weissbrich B, Huber M, Schneider EM, Weiss M. BK viremia in critically ill surgical patients with hemorrhagic or septic shock. BMC Res Notes. 2012 Feb 16;5:100. doi: 10.1186/1756-0500-5-100.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 5, 2013)
51
Original Estimated Enrollment
 (submitted: August 15, 2008)
20
Actual Study Completion Date December 2012
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT00736827
Other Study ID Numbers Anae_ICU_Ulm_BKV
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Manfred Weiss, University of Ulm
Study Sponsor University of Ulm
Collaborators University of Wuerzburg
Investigators
Principal Investigator: Manfred Weiss, MD, MBA University Hospital Ulm
PRS Account University of Ulm
Verification Date December 2015