Secondary Prophylaxis After Variceal Bleeding in Non-Responders

Cirrhosis Clinical Trial

— KT-2000  

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00450164
• Other study ID #: KT-2000
• Status: Completed
• Phase: Phase 4
• First received: March 20, 2007
• Last updated: March 20, 2007
• Start date: November 2000
• Est. completion date: June 2004

Study information

• Verified date: March 2007
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cirrhosis
• Gastrointestinal Hemorrhage
• Hypertension, Portal
• Portal Hypertension

Intervention

Procedure:
• esofagic varices ligation

Drug:
• Nadolol

• Isosorbide mononitrate

• Prazosin

Locations

Country	Name	City	State
Spain	Unidad de Sangrantes, HSCSP	Barcelona

Sponsors (1)

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

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compared efficacy (at least 6 moths of follow-up)
Secondary	Mortallity
Secondary	Rebleeding