Secondary Prophylaxis After Variceal Bleeding in Non-Responders (KT-2000)
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|ClinicalTrials.gov Identifier: NCT00450164|
Recruitment Status : Completed
First Posted : March 21, 2007
Last Update Posted : March 21, 2007
|Condition or disease||Intervention/treatment||Phase|
|Gastrointestinal Hemorrhage Portal Hypertension Cirrhosis||Procedure: esofagic varices ligation Drug: Nadolol Drug: Isosorbide mononitrate Drug: Prazosin||Phase 4|
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 (Clinical Trial)|
|Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
- Compared efficacy (at least 6 moths of follow-up)
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 ClinicalTrials.gov identifier (NCT number): NCT00450164
|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|