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The Effects of Clonidine on the Diuretic Response in Cirrhotic Patients

This study has been completed.
Sponsor:
Information provided by:
CHU de Charleroi
ClinicalTrials.gov Identifier:
NCT00356226
First received: July 24, 2006
Last updated: November 30, 2006
Last verified: October 2000
History of Changes
  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: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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:

MedlinePlus related topics: Cirrhosis
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:

ClinicalTrials.gov Identifier: NCT00356226     History of Changes
Other Study ID Numbers: HEP-05-1550.R2
Study First Received: July 24, 2006
Last Updated: November 30, 2006
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:
Liver Cirrhosis
Fibrosis
Liver Diseases
Digestive System Diseases
Pathologic Processes
Clonidine
Diuretics
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Sympatholytics
Autonomic Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics
Sensory System Agents
Central Nervous System Agents
Natriuretic Agents

ClinicalTrials.gov processed this record on May 19, 2013