Back to resultsThe Effects of Clonidine on the Diuretic Response in Cirrhotic Patients
Primary Purpose
Ascitic Cirrhosis, Hyperactivation of Sympathetic Nervous System
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
clonidine
Sponsored by
About this trial
This is an interventional treatment trial for Ascitic Cirrhosis focused on measuring norepinephrine, renin, aldosterone, hemodynamics, spironolactone
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
Sites / Locations
- ISPPC CHU de Charleroi
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00356226
Brief Title
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
2. Study Status
Record Verification Date
October 2000
Overall Recruitment Status
Completed
Study Start Date
October 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
CHU de Charleroi
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ascitic Cirrhosis, Hyperactivation of Sympathetic Nervous System
Keywords
norepinephrine, renin, aldosterone, hemodynamics, spironolactone
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Double
Allocation
Randomized
Enrollment
64 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
clonidine
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lenaerts Anne, MD
Organizational Affiliation
ISPPC CHU de Charleroi
Official's Role
Principal Investigator
Facility Information:
Facility Name
ISPPC CHU de Charleroi
City
Charleroi
ZIP/Postal Code
6000
Country
Belgium
12. IPD Sharing Statement
Citations:
PubMed Identifier
16505759
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.
Results Reference
background
PubMed Identifier
12014310
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.
Results Reference
background
PubMed Identifier
11395674
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.
Results Reference
background
PubMed Identifier
9295984
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.
Results Reference
background
PubMed Identifier
17006921
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.
Results Reference
result
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The Effects of Clonidine on the Diuretic Response in Cirrhotic Patients
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