Ignite Creation Date:
2024-05-05 @ 5:26 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00450164
Status:
COMPLETED
Last Update Posted:
2007-03-21
First Post:
2007-03-20
Brief Title:
Secondary Prophylaxis After Variceal Bleeding in Non-Responders
Sponsor:
Fundació Institut de Recerca de lHospital de la Santa Creu i Sant Pau
Organization:
Fundació Institut de Recerca de lHospital de la Santa Creu i Sant Pau
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2007-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
KT-2000
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None