Ascitic Cirrhosis Clinical Trial
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.
| NCT number | NCT00356226 |
| Other study ID # | HEP-05-1550.R2 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | July 24, 2006 |
| Last updated | November 30, 2006 |
| Start date | October 2000 |
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.
| Status | Completed |
| Enrollment | 64 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Belgium | ISPPC CHU de Charleroi | Charleroi |
| Lead Sponsor | Collaborator |
|---|---|
| CHU de Charleroi |
Belgium,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation