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The Effects of Clonidine on the Diuretic Response in Cirrhotic Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00356226
First Posted: July 25, 2006
Last Update Posted: December 4, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
CHU de Charleroi
  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
Intervention Model: Factorial Assignment
Masking: Double
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:


Further study details as provided by CHU de Charleroi:

Estimated Enrollment: 64
Study Start Date: October 2000
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: July 24, 2006
First Posted: July 25, 2006
Last Update Posted: December 4, 2006
Last Verified: October 2000

Keywords provided by CHU de Charleroi:
norepinephrine
renin
aldosterone
hemodynamics
spironolactone

Additional relevant MeSH terms:
Clonidine
Diuretics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents