Secondary Prophylaxis After Variceal Bleeding in Non-Responders - Tabular View

Tracking Information

First Received Date ^ICMJE

March 20, 2007

Last Updated Date

March 20, 2007

Start Date ^ICMJE

November 2000

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Compared efficacy (at least 6 moths of follow-up)

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Mortallity
Rebleeding

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Secondary Prophylaxis After Variceal Bleeding in Non-Responders

Official Title ^ICMJE

Secondary Prophylaxis After Variceal Bleeding: Combined Treatment With Endoscopic Ligation and Nadolol Against Nadolol Associated With Mononitrate of Isosorbide or Prazosin According to Hemodynamic Response.

Brief Summary

Controlled and randomized study comparing combined treatment (nadolol and endoscopic ligation) versus nadolol associated with isosorbide mononitrate or prazosin according to hemodynamic response, in the prevention of esofagic verices rebleeding.

Detailed Description

The present is a prospective, randomized, open label study, in parallel groups, in which the patients with hemorrhage caused by esofagic varices will be randomized in two groups of treatment, after control of acute hemorrhage.

All the patients included will receive standard medical treatment with beta - blockers and endoscopic ligation of the esofagic varices.

The control group will be constituted by the patients assigned to receive endoscopic ligation and nadolol (N).

The experimental group will be constituted by patients assigned to receive treatment according to the hemodynamic response.

All patients included in the experimental group will receive pharmacologic treatment with nadolol combined with Isosorbide Mononitrate (MNI) or Prazosin (PZ).

In both groups it will practice a basal hepatic hemodynamic study in the 4th-5th day after their admitance (after achieve hemodynamic stability for at least 48 h and with hemorrhage controlled) and a second control hepatic hemodynamic study 3-4 weeks after the beginning of the pharmacologic treatment, once adjusted doses.

In the experimental group, the responders to N + MNI will keep on this treatment, but nonrespondent in the hemodynamic study will switch treatment to N + PZ and a third hepatic hemodynamic study will be performed 3 to 4 weeks after the dosage adjustement.

The randomization will be stratified according to the degree of hepatic failure measured by Child-Pugh classification (classes A and B versus C) The design is random to avoid bias in the selection of the patients.

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Gastrointestinal Hemorrhage
Portal Hypertension
Cirrhosis

Intervention ^ICMJE

Procedure: esofagic varices ligation
Drug: Nadolol
Drug: Isosorbide mononitrate
Drug: Prazosin

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

June 2004

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Any Patient with endoscopically assessed Variceal Bleeding (esofagic and gastric)
Cirrhosis
Patient agreement to be included in the study onsentiment signed

Exclusion Criteria:

Any associated comorbidity with life expectancy lesser than 6 months
Patient refusement to be included in the study.
Pregnancy
Failure to control acute bleeding
Previous prophylaxis treatment

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Spain

Administrative Information

NCT ID ^ICMJE

NCT00450164

Responsible Party

Study ID Numbers ^ICMJE

KT-2000

Study Sponsor ^ICMJE

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Candid - Villanueva, Dr.

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Information Provided By

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Verification Date

March 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP