Utility of Renal Biomarkers in Cirrhosis | NCT01217983

Studies
Utility of Renal Biomarkers in Cirrhosis

NCT01217983

Sponsor

University Hospital, Geneva

Status

Completed

Last Update Posted

Oct 30, 2012Estimated

Enrollment

105Actual

Phase

Not provided

Conditions

Cirrhosis
Ascitis

Interventions

Not provided

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
PRD 2010-I-15	Other Grant/Funding Number	Projet de recherche et développement (PRD)

Status Module

Record Verification Date

Oct 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2010

Primary Completion Date

Oct 2012Actual

Completion Date

Oct 2012Actual

First Submitted Date

Oct 7, 2010

First Submission Date that Met QC Criteria

Oct 7, 2010

First Posted Date

Oct 8, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 29, 2012

Last Update Posted Date

Oct 30, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

105Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Measure	Description	Time Frame
Prediction of adverse clinical outcomes (Renal replacement therapy, transfer to ICU, all cause mortality).		30 days
Discrimination between different type of AKI.		30 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

All patients admitted for cirrhotic ascitis in the University Hospital of Geneva.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Belen Ponte, Md	Nephrology Division	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital of Geneva		Geneva		1211	Switzerland

Condition Browse Module

MeSH Terms

ID	Term
D005355	Fibrosis

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

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