跳至主要内容
临床试验/NCT00736827
NCT00736827已完成不适用

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

University of Ulm1 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2008年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
51
试验地点
1
主要终点
Association between BK virus reactivation and acute renal dysfunction

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Critically ill, postoperative/posttraumatic patients with threatening acute renal failure

排除标准

  • Life expectancy < 24 hours
  • Participation in other trials
  • Known or suspected pregnancy

结局指标

主要结局

Association between BK virus reactivation and acute renal dysfunction

时间窗: 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.

次要结局

  • 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.)

研究者

发起方
University of Ulm
申办方类型
Other
责任方
Principal Investigator
主要研究者

Manfred Weiss

Professor, MD, MBA

University of Ulm

研究点 (1)

Loading locations...

相似试验

Unknown
不适用
BK Viremia After Renal TransplantationTerminal Renal FailureBK Virus Infection
NCT00684372Karolinska University Hospital100
已完成
4 期
Multicenter Randomized Two-arms Study Evaluating the BK Viral Clearance in Kidney Transplant Recipients With BK Viremia.BK Virus Nephropathy After Kidney Transplantation
NCT03216967University Hospital, Strasbourg, France130
Unknown
4 期
Studying the Effect of Changing Immunosuppression in Case of Polyoma BK Virus Infection of the Renal TransplantDisorder Related to Renal TransplantationImmunosuppression Related Infectious DiseaseVirus Diseases
NCT01289301Hannover Medical School124
Unknown
不适用
Role of Anti-BK Virus Neutralizing Antibodies (BKV) as a Prognostic Marker for the Development of Nephropathy BKGraft Dysfunction
NCT02826811University Hospital, Strasbourg, France170
进行中(未招募)
1 期
Polyomavirus BK nephropathy after renal transplantation: Randomized clinical trial to demonstrate that switching to mTOR inhibitor is more effective than a reduction of immunosuppressive therapy - POLYOMA STUDYPolyoma BK-virus nephropathy is a viral complication after renal transplantation attacking up to 10% of renal transplants and causing transplant failure in 45% of cases. No virustatic treatment exists. Modifying the infection is usually tried by lowering immunosuppression, which may lead to transplant failure by rejection as well. A randomized switch of immunosuppression to everolimus vs general lowering of immunosuppression has to be tested (prospect. random. parallel group comparison).
EUCTR2008-005925-12-DEMedizinische Hochschule Hannover120