The Effects of Clonidine on the Diuretic Response in Cirr... | NCT00356226

Studies
The Effects of Clonidine on the Diuretic Response in Cirrhotic Patients

NCT00356226

Sponsor

CHU de Charleroi

Status

Completed

Last Update Posted

Dec 4, 2006Estimated

Enrollment

Phase

Not Applicable

Conditions

Ascitic Cirrhosis
Hyperactivation of Sympathetic Nervous System

Interventions

clonidine

Countries

Belgium

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

Status Module

Record Verification Date

Oct 2000

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 2000

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Jul 24, 2006

First Submission Date that Met QC Criteria

Jul 24, 2006

First Posted Date

Jul 25, 2006Estimated

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

Nov 30, 2006

Last Update Posted Date

Dec 4, 2006Estimated

Description Module

Brief Summary

To examine the effects of the addition of clonidine to diuretics on the mobilization of ascites at short-term (diuretic response and requirement of diuretics) and long-term (readmissions for tense ascites and requirement of diuretics) in cirrhotics with increased sympathetic nervous system. Secondary objectives were to study neuro-hormonal,hemodynamic effects and side effects of clonidine and diuretics.

Detailed Description

Not provided

Design Module

Study Type

Interventional

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 Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
clonidine	Drug

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Cirrhotic patients with ascites
Plasma norepinephrine level > 300 pg/mL (normal value: 185 - 275 pg/mL)

Exclusion Criteria:

Serum bilirubin concentration above 4.5 mg/dL
Prothrombin time below 40%
Platelet count below 40 X 10¨9/liter
Serum creatinine concentration above 2 mg/dL
Gastro-intestinal hemorrhage
Alcoholic hepatitis
Diabetes mellitus,
Hepatocellular carcinoma
Respiratory or cardiac failures
Hepatic encephalopathy
Bacterial infection

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lenaerts Anne, MD	ISPPC CHU de Charleroi	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
ISPPC CHU de Charleroi		Charleroi		6000	Belgium

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16505759	Background	Lenaerts A, Codden T, Henry JP, Legros F, Ligny G. Comparative pilot study of repeated large volume paracentesis vs the combination on clonidine-spironolactone in the treatment of cirrhosis-associated refractory ascites. Gastroenterol Clin Biol. 2005 Nov;29(11):1137-42. doi: 10.1016/s0399-8320(05)82178-5.
12014310	Background

ID	Term
D048288	Imidazolines
D007093	Imidazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring