BK Virus and Renal Dysfunction in Postoperative/Posttraumatic Critically Ill Patients (BICUK)
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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 |
- 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 ]
- 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
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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 |
Postoperative/posttraumatic critically ill patients admitted to the intensive care unit
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
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 Toxemia Disease Attributes |
Pathologic Processes Kidney Diseases Urologic Diseases Shock Infection Systemic Inflammatory Response Syndrome Inflammation |
ClinicalTrials.gov processed this record on May 19, 2013