The Effects of Clonidine on the Diuretic Response in Cirrhotic Patients
Information source: CHU de Charleroi
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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
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.
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
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
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
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