Clinical trial NCT00356226: The Effects of Clonidine on the Diuretic Response in Cirrhotic Patients
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ascitic Cirrhosis
Hyperactivation of Sympathetic Nervous System
Keywords: norepinephrine
renin
aldosterone
hemodynamics
spironolactone
Lead sponsor: CHU de Charleroi
Sponsor class: OTHER
First posted: 2006-07-25
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Charleroi
country: Belgium
facility: ISPPC CHU de Charleroi
Study officials:
affiliation: ISPPC CHU de Charleroi
name: Lenaerts Anne, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.
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. No abstract available. French.
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. doi: 10.1002/hep.21355.