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

This study has been completed.
Sponsor:
Collaborator:
University of Wuerzburg
Information provided by (Responsible Party):
Manfred Weiss, University of Ulm
ClinicalTrials.gov Identifier:
NCT00736827
First received: August 15, 2008
Last updated: February 5, 2013
Last verified: February 2013
  Purpose

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.


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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: BK Virus and Renal Dysfunction in Postoperative/Posttraumatic Critically Ill Patients

Resource links provided by NLM:


Further study details as provided by University of Ulm:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Whole blood, serum, white blood cells; urine


Enrollment: 51
Study Start Date: August 2008
Study Completion Date: December 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
A
Postoperative/posttraumatic surgical critically ill patients with septic or haemorrhagic shock with threatening acute renal failure

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Postoperative/posttraumatic critically ill patients admitted to the intensive care unit

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00736827

Locations
Germany
Clinic of Anesthesiology
Ulm, Germany, 89070
Sponsors and Collaborators
University of Ulm
University of Wuerzburg
Investigators
Principal Investigator: Manfred Weiss, MD, MBA University Hospital Ulm
  More Information

Additional Information:
No publications provided

Responsible Party: Manfred Weiss, Professor, MD, MBA, University of Ulm
ClinicalTrials.gov Identifier: NCT00736827     History of Changes
Other Study ID Numbers: Anae_ICU_Ulm_BKV
Study First Received: August 15, 2008
Last Updated: February 5, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by University of Ulm:
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

Additional relevant MeSH terms:
Critical Illness
Acute Kidney Injury
Multiple Organ Failure
Renal Insufficiency
Sepsis
Disease Attributes
Pathologic Processes
Kidney Diseases
Urologic Diseases
Shock
Infection
Systemic Inflammatory Response Syndrome
Inflammation

ClinicalTrials.gov processed this record on August 28, 2014