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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00450164
Recruitment Status : Completed
First Posted : March 21, 2007
Last Update Posted : March 21, 2007
Information provided by:
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

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.

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

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : November 2000
Actual Study Completion Date : June 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

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

Secondary Outcome Measures :
  1. Mortallity
  2. Rebleeding

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00450164

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Unidad de Sangrantes, HSCSP
Barcelona, Spain, 08025
Sponsors and Collaborators
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
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Principal Investigator: Candid - Villanueva, Dr. Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Layout table for additonal information Identifier: NCT00450164    
Other Study ID Numbers: KT-2000
First Posted: March 21, 2007    Key Record Dates
Last Update Posted: March 21, 2007
Last Verified: March 2007
Keywords provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:
Variceal bleeding
Secondary profilaxis
Portal hypertension
Additional relevant MeSH terms:
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Hypertension, Portal
Gastrointestinal Hemorrhage
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Liver Diseases
Digestive System Diseases
Gastrointestinal Diseases
Isosorbide Dinitrate
Diuretics, Osmotic
Natriuretic Agents
Physiological Effects of Drugs
Vasodilator Agents
Nitric Oxide Donors
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Adrenergic beta-Antagonists
Anti-Arrhythmia Agents