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

This study has been completed.
Sponsor:
Information provided by:
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier:
NCT00450164
First received: March 20, 2007
Last updated: NA
Last verified: March 2007
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Gastrointestinal Hemorrhage
Portal Hypertension
Cirrhosis
Procedure: esofagic varices ligation
Drug: Nadolol
Drug: Isosorbide mononitrate
Drug: Prazosin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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.

Resource links provided by NLM:


Further study details as provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:

Primary Outcome Measures:
  • Compared efficacy (at least 6 moths of follow-up)

Secondary Outcome Measures:
  • Mortallity
  • Rebleeding

Estimated Enrollment: 50
Study Start Date: November 2000
Study Completion Date: June 2004
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00450164

Locations
Spain
Unidad de Sangrantes, HSCSP
Barcelona, Spain, 08025
Sponsors and Collaborators
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00450164     History of Changes
Other Study ID Numbers: KT-2000
Study First Received: March 20, 2007
Last Updated: March 20, 2007
Health Authority: Spain: Ethics Committee

Keywords provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:
Variceal bleeding
Secondary profilaxis
Hemodynamic
Portal hypertension

Additional relevant MeSH terms:
Gastrointestinal Hemorrhage
Hemorrhage
Hypertension
Hypertension, Portal
Liver Cirrhosis
Fibrosis
Gastrointestinal Diseases
Digestive System Diseases
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Liver Diseases
Isosorbide
Isosorbide-5-mononitrate
Isosorbide Dinitrate
Nadolol
Prazosin
Diuretics, Osmotic
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Nitric Oxide Donors
Molecular Mechanisms of Pharmacological Action
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents

ClinicalTrials.gov processed this record on July 23, 2014