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

NCT ID: NCT00736827

Last Updated: 2015-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

51 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-08-31

Study Completion Date

2012-12-31

Brief Summary

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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

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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.

Conditions

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Acute Renal Failure SIRS Sepsis Critically Ill Multiple Organ Dysfunction Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with non-septic shock

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

No interventions assigned to this group

Patients with septic shock

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Wuerzburg

OTHER

Sponsor Role collaborator

University of Ulm

OTHER

Sponsor Role lead

Responsible Party

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Manfred Weiss

Professor, MD, MBA

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Manfred Weiss, MD, MBA

Role: PRINCIPAL_INVESTIGATOR

University Hospital Ulm

Locations

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Clinic of Anesthesiology

Ulm, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type RESULT
PMID: 22339896 (View on PubMed)

Related Links

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http://www.biomedcentral.com/1756-0500/5/100

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

Other Identifiers

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Anae_ICU_Ulm_BKV

Identifier Type: -

Identifier Source: org_study_id