The Effects of Clonidine on the Diuretic Response in Cirrhotic Patients

NCT00356226 | Completed

• 1 other identifier: HEP-05-1550.R2
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Ascitic Cirrhosis; Hyperactivation of Sympathetic Nervous System

Keywords

norepinephrine; renin; aldosterone; hemodynamics; spironolactone

Interventions

clonidine DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cirrhotic patients with ascites
• Plasma norepinephrine level \> 300 pg/mL (normal value: 185 - 275 pg/mL)

You may not qualify if:

• 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

Sponsors & Collaborators

• CHU de Charleroi: lead

Study Sites (1)

ISPPC CHU de Charleroi

Charleroi, 6000, Belgium

Location

Related Publications (5)

• 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.

  PMID: 16505759 BACKGROUND

• 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.

  PMID: 12014310 BACKGROUND

• 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.

  PMID: 11395674 BACKGROUND

• 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.

  PMID: 9295984 BACKGROUND

• 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.

  PMID: 17006921 RESULT

MeSH Terms

Interventions

Clonidine

Intervention Hierarchy (Ancestors)

Imidazolines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Lenaerts Anne, MD

  ISPPC CHU de Charleroi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 24, 2006
• First Posted: July 25, 2006
• Study Start: October 1, 2000
• Last Updated: December 4, 2006

Record last verified: 2000-10

Locations

BE (1)