Utility of Renal Biomarkers in Cirrhosis

Cirrhosis Clinical Trial

Official title:

Utility of Renal Biomarkers in Cirrhotic Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01217983
• Other study ID #: 10-056 Med 10-019
• Secondary ID: PRD 2010-I-15
• Status: Completed
• Phase: N/A
• First received: October 7, 2010
• Last updated: October 29, 2012
• Start date: October 2010
• Est. completion date: October 2012

Study information

• Verified date: October 2012
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Federal Office of Public Health
• Study type: Observational

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Ascitis
• Cirrhosis
• Liver Cirrhosis

Locations

Country	Name	City	State
Switzerland	University Hospital of Geneva	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	30 days	No
Secondary	Prediction of adverse clinical outcomes (Renal replacement therapy, transfer to ICU, all cause mortality).		30 days	No
Secondary	Discrimination between different type of AKI.		30 days	No
Secondary	Prediction of AKI developement using renal artery resistive indexes.		30 days	No