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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00736827

Acronym

BICUK

Enrollment

Registered

2008-08-18

Start date

2008-08-31

Completion date

2012-12-31

Last updated

2015-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	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

Measure	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.

Countries

Germany

Outcome results