Secondary Prophylaxis After Variceal Bleeding in Non-Responders (KT-2000)

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.

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.

Study Overview

• Status: Completed
• Conditions: Cirrhosis; Portal Hypertension; Gastrointestinal Hemorrhage
• Intervention / Treatment: Drug: Prazosin; Procedure: esofagic varices ligation; Drug: Nadolol; Drug: Isosorbide mononitrate

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 Type: Interventional
• Enrollment: 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08025
    • Unidad de Sangrantes, HSCSP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Mortallity
Rebleeding

Collaborators and Investigators

• Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Investigators: Principal Investigator: Candid - Villanueva, Dr., Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Study record dates

Study Major Dates

• Study Start: November 1, 2000
• Study Completion (ACTUAL): June 1, 2004

Study Registration Dates

• First Submitted: March 20, 2007
• First Submitted That Met QC Criteria: March 20, 2007
• First Posted (ESTIMATE): March 21, 2007

Study Record Updates

• Last Update Posted (ESTIMATE): March 21, 2007
• Last Update Submitted That Met QC Criteria: March 20, 2007
• Last Verified: March 1, 2007

More Information

Terms related to this study

• Keywords: Hemodynamic; Portal hypertension; Variceal bleeding; Secondary profilaxis
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Gastrointestinal Diseases; Liver Diseases; Hypertension; Hemorrhage; Hypertension, Portal; Gastrointestinal Hemorrhage; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Vasodilator Agents; Autonomic Agents; Peripheral Nervous System Agents; Natriuretic Agents; Diuretics, Osmotic; Diuretics; Sympatholytics; Adrenergic alpha-1 Receptor Antagonists; Adrenergic alpha-Antagonists; Nitric Oxide Donors; Isosorbide; Isosorbide Dinitrate; Isosorbide-5-mononitrate; Nadolol; Prazosin
• Other Study ID Numbers: KT-2000