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Utility of Renal Biomarkers in Cirrhosis

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ClinicalTrials.gov Identifier: NCT01217983
Recruitment Status : Completed
First Posted : October 8, 2010
Last Update Posted : October 30, 2012
Information provided by (Responsible Party):
Ponte Belen, University Hospital, Geneva

Brief 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 pre-renal causes. Finally the investigators hypothesized that such biomarkers could predict short-term outcome in this population.

Condition or disease
Cirrhosis Ascitis

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Study Type : Observational
Actual Enrollment : 105 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Utility of Renal Biomarkers in Cirrhotic Patients
Study Start Date : October 2010
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Prediction of adverse clinical outcomes (Renal replacement therapy, transfer to ICU, all cause mortality). [ Time Frame: 30 days ]
  2. Discrimination between different type of AKI. [ Time Frame: 30 days ]
  3. Prediction of AKI developement using renal artery resistive indexes. [ Time Frame: 30 days ]

Biospecimen Retention:   Samples Without DNA
Plasma, serum, urine and ascitis

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All patients admitted for cirrhotic ascitis in the University Hospital of Geneva.

Inclusion Criteria:

  • Age ≥ 18 years
  • Known or suspected cirrhosis
  • Suspected ascitis
  • Informed consent signed

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01217983

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University Hospital of Geneva
Geneva, Switzerland, 1211
Sponsors and Collaborators
University Hospital, Geneva
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Principal Investigator: Belen Ponte, Md Nephrology Division
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Responsible Party: Ponte Belen, Dr, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT01217983    
Other Study ID Numbers: 10-056 Med 10-019
PRD 2010-I-15 ( Other Grant/Funding Number: Projet de recherche et développement (PRD) )
First Posted: October 8, 2010    Key Record Dates
Last Update Posted: October 30, 2012
Last Verified: October 2012
Additional relevant MeSH terms:
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Liver Cirrhosis
Pathologic Processes
Liver Diseases
Digestive System Diseases