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

Sepsis Clinical Trial

— BICUK  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00736827
• Other study ID #: Anae_ICU_Ulm_BKV
• Status: Completed
• Phase: N/A
• First received: August 15, 2008
• Last updated: December 2, 2015
• Start date: August 2008
• Est. completion date: December 2012

Study information

• Verified date: December 2015
• Source: University of Ulm
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: December 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Kidney Injury
• Acute Renal Failure
• Critical Illness
• Critically Ill
• Multiple Organ Dysfunction Syndrome
• Multiple Organ Failure
• Renal Insufficiency
• Sepsis
• SIRS

Locations

Country	Name	City	State
Germany	Clinic of Anesthesiology	Ulm

Sponsors (2)

Lead Sponsor	Collaborator
University of Ulm	University of Wuerzburg

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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.	No

External Links

•   Nass M, Weissbrich B, Huber M, Schneider EM, Weiss M. BK viremia in critically ill surgical patients with hemorrhagic or septic shock. BMC Research Notes 2012; 5:100 (16 Februar 2012). doi:10.1186/1756-0500-5-100