The Effects of Clonidine on the Diuretic Response in Cirrhotic Patients

CHU de Charleroi

Status: Completed

Conditions: Ascitic Cirrhosis; Hyperactivation of Sympathetic Nervous System

Treatments: Drug: clonidine

Study type: Interventional

Funder types: Other

Identifiers

NCT00356226

HEP-05-1550.R2

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind