Acute Renal FailureBICUKNCT00736827
BK Virus and Renal Dysfunction in Postoperative/Posttraumatic Critically Ill Patients
An observational study of Acute Renal Failure and SIRS, run by University of Ulm at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Renal Failure, SIRS, Sepsis
- How many people
- 51 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2008to Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Postoperative/posttraumatic critically ill patients admitted to the intensive care unit
Who may be able to join
- Critically ill, postoperative/posttraumatic patients with threatening acute renal failure
Who cannot join
- Life expectancy < 24 hours
- Participation in other trials
- Known or suspected pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- 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
- Medical subject headings
- Acute Kidney Injury, Sepsis, Critical Illness, Multiple Organ Failure, Multiple Trauma, Inflammation, Infections, Systemic Inflammatory Response Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between BK virus reactivation and acute renal dysfunction
Measured: 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.
Measured: First day of acute renal dysfunction, first days on hemodiafiltration, first day after hemodiafiltration, before demission from intensive care unit or death.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2008 (estimated)
- Study startAug 2008
- Primary completionAug 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Renal FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ulm
- Sponsor type
- University, hospital or other
- Collaborators
- University of Wuerzburg
- Responsible party
- Principal investigator, Manfred Weiss, University of Ulm
- Investigators
- Manfred Weiss, MD, MBA, Principal investigator, University Hospital Ulm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00736827
- Sponsor's protocol ID
- Anae_ICU_Ulm_BKV
- Acronym
- BICUK
- Status last verified
- Dec 2015
- First submitted
- 15 Aug 2008
- Last updated
- 4 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22339896
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BK Virus and Renal Dysfunction in Postoperative/Posttraumatic Critically Ill Patients
- ClinicalTrials.gov ID
- NCT00736827
- Acronym / sponsor ID
- BICUK / Anae_ICU_Ulm_BKV
- Keywords
- BK virus, acute renal failure, hemodiafiltration, humans, patients, polytrauma, surgery, complement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of UlmUniversity, hospital or other
- Collaborators
- University of Wuerzburg
- Study start
- Aug 2008
- Primary completion
- Aug 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 18 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Postoperative/posttraumatic critically ill patients admitted to the intensive care unit
Key inclusion criteria (1 listed)
- Critically ill, postoperative/posttraumatic patients with threatening acute renal failure
Key exclusion criteria (3 listed)
- Life expectancy < 24 hours
- Participation in other trials
- Known or suspected pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2015.
- Results publication: PubMed 22339896Nass 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.
- Nass M, Weissbrich B, Huber M, Schneider EM, Weiss M. BK viremia in critically ill surgical patients with hemorrhagic or septic shock. BMC Research Notes 2012; 5:100 (16 Februar 2012). doi:10.1186/1756-0500-5-100Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manfred Weiss, MD, MBA principal investigator
University Hospital Ulm
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Renal Failure and SIRS, run by University of Ulm at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00736827, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2015.