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The Effects of Clonidine on the Diuretic Response in Cirrhotic Patients

NCT ID: NCT00356226

Last Updated: 2006-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-10-31

Brief Summary

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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

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Conditions

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Ascitic Cirrhosis Hyperactivation of Sympathetic Nervous System

Keywords

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norepinephrine renin aldosterone hemodynamics spironolactone

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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clonidine

Intervention Type DRUG

Eligibility Criteria

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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 10ยจ9/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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CHU de Charleroi

OTHER

Sponsor Role lead

Principal Investigators

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Lenaerts Anne, MD

Role: PRINCIPAL_INVESTIGATOR

ISPPC CHU de Charleroi

Locations

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ISPPC CHU de Charleroi

Charleroi, , Belgium

Site Status

Countries

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Belgium

References

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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.

Reference Type BACKGROUND
PMID: 16505759 (View on PubMed)

Lenaerts A, Codden T, Van Cauter J, Meunier JC, Henry JP, Ligny G. Interest of the association clonidine-spironolactone in cirrhotic patients with ascites and activation of sympathetic nervous system. Acta Gastroenterol Belg. 2002 Jan-Mar;65(1):1-5.

Reference Type BACKGROUND
PMID: 12014310 (View on PubMed)

Lenaerts A, Codden T, Henry JP, Van Cauter J, Meunier JC, Ligny G. [Biological factors influencing response to diuretics in patients with cirrhosis and ascites]. Gastroenterol Clin Biol. 2001 Mar;25(3):268-72. French.

Reference Type BACKGROUND
PMID: 11395674 (View on PubMed)

Lenaerts A, Van Cauter J, Moukaiber H, Meunier JC, Ligny G. [Treatment of refractory ascites with clonidine and spironolactone]. Gastroenterol Clin Biol. 1997;21(6-7):524-5. No abstract available. French.

Reference Type BACKGROUND
PMID: 9295984 (View on PubMed)

Lenaerts A, Codden T, Meunier JC, Henry JP, Ligny G. Effects of clonidine on diuretic response in ascitic patients with cirrhosis and activation of sympathetic nervous system. Hepatology. 2006 Oct;44(4):844-9. doi: 10.1002/hep.21355.

Reference Type RESULT
PMID: 17006921 (View on PubMed)

Other Identifiers

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HEP-05-1550.R2

Identifier Type: -

Identifier Source: org_study_id