CirrhosisNCT01217983
Utility of Renal Biomarkers in Cirrhosis
An observational study of Cirrhosis and Ascitis, run by University Hospital, Geneva at 1 site in Switzerland.
Trial summary
Evaluation of kidney function is critical in cirrhotic patients as there is a clear relationship between renal failure and prognosis. The investigators hypothesized that in this population new biomarkers of renal function could help in early detection of acute renal failure and in discrimination between renal and… Read more about this study
- Who is it for?
- Ages 18 years and older
- How many people
- 105 participants
- Where
- 1 siteSwitzerland
- Study dates
- Oct 2010to Oct 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: All patients admitted for cirrhotic ascitis in the University Hospital of Geneva.
Who may be able to join
- Age ≥ 18 years
- Known or suspected cirrhosis
- Suspected ascitis
- Informed consent signed
Who cannot join
- Proven multifocal hepatocellular carcinoma
- Acute gastric hemorrhage (active or < 2 weeks)
- Known end-stage renal disease or on dialysis before admission
- Recipients of kidney or liver transplants
- Transferred from another institution
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Utility of Renal Biomarkers in Cirrhotic Patients
Evaluation of kidney function is critical in cirrhotic patients as there is a clear relationship between renal failure and prognosis. The investigators hypothesized that in this population new biomarkers of renal function could help in early detection of acute renal failure and in discrimination between renal and pre-renal causes. Finally the investigators hypothesized that such biomarkers could predict short-term outcome in this population.
- Medical subject headings
- Fibrosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Early detection of acute kidney injury in hospitalized cirrhotic patients with ascitis using new renal biomarkers
Acute kidney injury will be defined using RIFLE and AKIN criteria.
Measured: 30 days
Secondary outcomes (3)
Prediction of adverse clinical outcomes (Renal replacement therapy, transfer to ICU, all cause mortality).
Measured: 30 days
Discrimination between different type of AKI.
Measured: 30 days
Prediction of AKI developement using renal artery resistive indexes.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ponte Belen, University Hospital, Geneva
- Investigators
- Belen Ponte, Md, Principal investigator, Nephrology Division
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01217983
- Sponsor's protocol ID
- 10-056 Med 10-019
- Other IDs
- PRD 2010-I-15
- Status last verified
- Oct 2012
- First submitted
- 7 Oct 2010
- Last updated
- 30 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility of Renal Biomarkers in Cirrhotic Patients
- ClinicalTrials.gov ID
- NCT01217983
- Acronym / sponsor ID
- 10-056 Med 10-019
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 8 Oct 2010 (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.
Evaluation of kidney function is critical in cirrhotic patients as there is a clear relationship between renal failure and prognosis. The investigators hypothesized that in this population new biomarkers of renal function could help in early detection of acute renal failure and in discrimination between renal and pre-renal causes. Finally the investigators hypothesized that such biomarkers could predict short-term outcome in this population.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients admitted for cirrhotic ascitis in the University Hospital of Geneva.
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Known or suspected cirrhosis
- Suspected ascitis
- Informed consent signed
Key exclusion criteria (5 listed)
- Proven multifocal hepatocellular carcinoma
- Acute gastric hemorrhage (active or < 2 weeks)
- Known end-stage renal disease or on dialysis before admission
- Recipients of kidney or liver transplants
- Transferred from another institution
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
Early detection of acute kidney injury in hospitalized cirrhotic patients with ascitis using new renal biomarkers
Time frame: 30 days
Acute kidney injury will be defined using RIFLE and AKIN criteria.
3 secondary outcomes
Prediction of adverse clinical outcomes (Renal replacement therapy, transfer to ICU, all cause mortality).
Time frame: 30 days
Discrimination between different type of AKI.
Time frame: 30 days
Prediction of AKI developement using renal artery resistive indexes.
Time frame: 30 days
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 30 Oct 2012.
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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.
Belen Ponte, Md principal investigator
Nephrology Division
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 Cirrhosis and Ascitis, run by University Hospital, Geneva at 1 site in Switzerland.
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 4 inclusion and 5 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 30 Oct 2012. 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 Switzerland. 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?
Early detection of acute kidney injury in hospitalized cirrhotic patients with ascitis using new renal biomarkers (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Oct 2012; AzTrials last refreshed its copy on 8 Nov 2026.