NCT00736827

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

August 15, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 18, 2008

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

December 4, 2015

Status Verified

December 1, 2015

Enrollment Period

4 years

First QC Date

August 15, 2008

Last Update Submit

December 2, 2015

Conditions

Keywords

BK virusacute renal failurehemodiafiltrationhumanspatientspolytraumasurgerycomplementinflammationinflammatory responsebiomarkerscytokinescell surface markersfunctional polymorphismsinfectionssystemic inflammatory response syndromeSIRSsepsissevere sepsisshockorgan dysfunctionsSOFAseverity of diseaseAPACHEIISAPSIISPAPS3length of stayoutcomemortality

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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.

Study Arms (2)

Patients with non-septic shock

Postoperative/posttraumatic surgical critically ill patients with non-septic shock with threatening acute renal failure

Patients with septic shock

Postoperative/posttraumatic surgical critically ill patients with septic shock with threatening acute renal failure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinic of Anesthesiology

Ulm, 89070, Germany

Location

Related Publications (1)

  • 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.

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, serum, white blood cells; urine

MeSH Terms

Conditions

Acute Kidney InjurySepsisCritical IllnessMultiple Organ FailureMultiple TraumaInflammationInfectionsSystemic Inflammatory Response SyndromeShock

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsDisease AttributesWounds and Injuries

Study Officials

  • Manfred Weiss, MD, MBA

    University Hospital Ulm

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, MD, MBA

Study Record Dates

First Submitted

August 15, 2008

First Posted

August 18, 2008

Study Start

August 1, 2008

Primary Completion

August 1, 2012

Study Completion

December 1, 2012

Last Updated

December 4, 2015

Record last verified: 2015-12

Locations