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The Effects of Clonidine on the Diuretic Response in Cirrhotic Patients

Information source: CHU de Charleroi
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Ascitic Cirrhosis; Hyperactivation of Sympathetic Nervous System

Intervention: clonidine (Drug)

Phase: N/A

Status: Completed

Sponsored by: CHU de Charleroi

Official(s) and/or principal investigator(s):
Lenaerts Anne, MD, Principal Investigator, Affiliation: ISPPC CHU de Charleroi


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.

Clinical Details

Official title: The Effects of Clonidine on the Diuretic Response in Cirrhotic Patients With Ascites and Activation of Sympathetic Nervous System: a Randomized Double-Blind Placebo Controlled Study.

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Locations and Contacts

ISPPC CHU de Charleroi, Charleroi 6000, Belgium
Additional Information

Related publications:

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.

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.

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.

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. French.

Starting date: October 2000
Last updated: November 30, 2006

Page last updated: August 20, 2015

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