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

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.

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Key information

Conditions

Acute Renal Failure Acute Kidney Injury Critical Illness Critically Ill Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Inflammation Kidney Diseases Male Urogenital Diseases Multiple Organ Dysfunction Syndrome Multiple Organ Failure Multiple Trauma Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency SIRS Sepsis Shock Systemic Inflammatory Response Syndrome Urogenital Diseases Urologic Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinic of Anesthesiology

Ulm, 89070, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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.

Secondary outcomes

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.

Sponsors and collaborators

Lead sponsor

University of Ulm

Other

Collaborators

University of Wuerzburg

Registry information

Acronym: BICUK

Important dates

Study start: 2008
Primary completion: 2012
Study completion: 2012
First posted: Aug 18, 2008
Registry last updated: Dec 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed