Clinical trial NCT00736827: BK Virus and Renal Dysfunction in Postoperative/Posttraumatic Critically Ill Patients
Official title: BK Virus and Renal Dysfunction in Postoperative/Posttraumatic Critically Ill Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Renal Failure
SIRS
Sepsis
Critically Ill
Multiple Organ Dysfunction Syndrome
Keywords: 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
Lead sponsor: University of Ulm
Sponsor class: OTHER
Collaborators: name: University of Wuerzburg
First posted: 2008-08-18
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Postoperative/posttraumatic critically ill patients admitted to the intensive care unit

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.

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

Primary outcomes:
measure: Association between BK virus reactivation and acute renal dysfunction
timeFrame: 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:
measure: Pattern of biomarkers and surface markers on leukocytes.
timeFrame: First day of acute renal dysfunction, first days on hemodiafiltration, first day after hemodiafiltration, before demission from intensive care unit or death.
Other outcomes:
Locations:
city: Ulm
country: Germany
facility: Clinic of Anesthesiology
Study officials:
affiliation: University Hospital Ulm
name: Manfred Weiss, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.