- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00450164
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.
Study Overview
Status
Intervention / Treatment
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
Enrollment
Phase
- Phase 4
Contacts and Locations
Study Locations
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-
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Barcelona, Spain, 08025
- Unidad de Sangrantes, HSCSP
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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Collaborators and Investigators
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
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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