The Effects of Clonidine on the Diuretic Response in Cirrhotic Patients - Full Text View

Sponsor:	CHU de Charleroi
Information provided by:	CHU de Charleroi
ClinicalTrials.gov Identifier:	NCT00356226

Purpose

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.

Condition	Intervention
Ascitic Cirrhosis Hyperactivation of Sympathetic Nervous System	Drug: clonidine

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Safety/Efficacy Study
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.

Resource links provided by NLM:

Drug Information available for: Clonidine Clonidine hydrochloride

U.S. FDA Resources

Further study details as provided by CHU de Charleroi:

Estimated Enrollment:	64
Study Start Date:	October 2000

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00356226

Locations

Belgium
ISPPC CHU de Charleroi
Charleroi, Belgium, 6000

Sponsors and Collaborators

CHU de Charleroi

Investigators

Principal Investigator:

Lenaerts Anne, MD

ISPPC CHU de Charleroi

More Information

Publications:

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.

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. No abstract available.

Study ID Numbers:	HEP-05-1550.R2
Study First Received:	July 24, 2006
Last Updated:	November 30, 2006
ClinicalTrials.gov Identifier:	NCT00356226 History of Changes
Health Authority:	Belgium: Ministry of Social Affairs, Public Health and the Environment

Keywords provided by CHU de Charleroi:

norepinephrine
renin
aldosterone
hemodynamics
spironolactone

Additional relevant MeSH terms:

Sympatholytics
Neurotransmitter Agents
Adrenergic alpha-Agonists
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Fibrosis
Clonidine
Diuretics
Physiological Effects of Drugs
Cardiovascular Agents
Antihypertensive Agents

Adrenergic Agonists
Pharmacologic Actions
Pathologic Processes
Natriuretic Agents
Autonomic Agents
Sensory System Agents
Therapeutic Uses
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 09, 2010