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

Study Overview
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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.

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

Conditions
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Acute Renal Failure, SIRS, Sepsis, Critically Ill, Multiple Organ Dysfunction Syndrome

Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with non-septic shock<br>Postoperative/posttraumatic surgical critically ill patients with non-septic shock with threatening acute renal failure | |
| Patients with septic shock<br>Postoperative/posttraumatic surgical critically ill patients with septic shock with threatening acute renal failure | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BK virus, acute renal failure, hemodiafiltration, humans, patients, polytrauma, surgery, complement, inflammation, inflammatory response, biomarkers, cytokines, cell surface markers, functional polymorphisms, infections, systemic inflammatory response syndrome, SIRS, sepsis, severe sepsis, shock, organ dysfunctions, SOFA, severity of disease, APACHEII, SAPSII, SPAPS3, length of stay, outcome, mortality