Secondary Prophylaxis After Variceal Bleeding in Non-Responders (KT-2000)
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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. |
- Compared efficacy (at least 6 moths of follow-up)
- Mortallity
- Rebleeding
| Estimated Enrollment: | 50 |
| Study Start Date: | November 2000 |
| Study Completion Date: | June 2004 |
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 |
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| Spain | |
| Unidad de Sangrantes, HSCSP | |
| Barcelona, Spain, 08025 | |
| 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 May 21, 2013