Back to resultsHemodynamic Profile of Terlipressin and Octreotide in Patients With Cirrhosis and Portal Hypertension. A Randomised, Single Blinded Clinical Trial. (INFUTER)
Primary Purpose
Liver Cirrhosis Portal
Status
Unknown status
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Terlipressin
Terlipressin
Octreotide
Sponsored by
About this trial
This is an interventional treatment trial for Liver Cirrhosis Portal
Eligibility Criteria
Inclusion Criteria:
- Age: 18-75 years old.
- Liver Cirrhosis
- Portal hypertension
- Stable disease in the absence of vasoactive agents
- Signed informed consent form
Exclusion Criteria:
- 1. Patients on medications that can prolong QT interval 2. Patients with HCC not fulfilling Milan criteria for transplant 3. Grade II-IV hepatic encephalopathy 4. GI bleeding in the last 10 days 5. Child-Pugh C above 12 points 6. Bacterial infection in the last 10 days 7. HVPG <12mmHg 8. Plasma sodium <130mmol/l 9. Serum creatinine >2mg/dl 10. Serum bilirubin >5mg/dl 11. INR>2.5 12. Uncontrolled cardiovascular disease 13. HIV infection 14. Extra hepatic malignancies 15. Heart failure NYHA Grade III/IV, COPD GOLD>2 16. Morbid obesity 17. Coronary heart disease or intestinal ischemia 18. Pregnancy or breastfeeding
Sites / Locations
- Hospital Clinic
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Terlipressin IV bolus
Terlipressin IV continuous infusion
Octreotide IV bolus plus continuous infusion
Arm Description
Terlipressin 1mg IV bolus
Terlipressin by IV continuous infusion at a rate of 2mg/day (max 4mg/day) during 2 hours
Octreotide 50mcg IV bolus plus continuous infusion at a rate of 50mcg/h during 2 hours
Outcomes
Primary Outcome Measures
Change in HVPG
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04353193
Brief Title
Hemodynamic Profile of Terlipressin and Octreotide in Patients With Cirrhosis and Portal Hypertension. A Randomised, Single Blinded Clinical Trial.
Acronym
INFUTER
Official Title
Hemodynamic Profile of Terlipressin and Octreotide in Patients With Cirrhosis and Portal Hypertension. A Randomised, Single Blinded Clinical Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 2020 (Anticipated)
Primary Completion Date
February 2022 (Anticipated)
Study Completion Date
May 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Juan A. Arnaiz
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Clinical trial to compare the effects of terlipressin and octreotide in the reduction of portal hypertension measured as hepatic venous pressure gradient (HVPG) in patients with liver cirrhosis
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cirrhosis Portal
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
single blind
Allocation
Randomized
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Terlipressin IV bolus
Arm Type
Experimental
Arm Description
Terlipressin 1mg IV bolus
Arm Title
Terlipressin IV continuous infusion
Arm Type
Experimental
Arm Description
Terlipressin by IV continuous infusion at a rate of 2mg/day (max 4mg/day) during 2 hours
Arm Title
Octreotide IV bolus plus continuous infusion
Arm Type
Experimental
Arm Description
Octreotide 50mcg IV bolus plus continuous infusion at a rate of 50mcg/h during 2 hours
Intervention Type
Drug
Intervention Name(s)
Terlipressin
Intervention Description
Terlipressin 1mg IV bolus
Intervention Type
Drug
Intervention Name(s)
Terlipressin
Intervention Description
Terlipressin by IV continuous infusion at a rate of 2mg/day (max 4mg/day) during 2 hours
Intervention Type
Drug
Intervention Name(s)
Octreotide
Intervention Description
Octreotide 50mcg IV bolus plus continuous infusion at a rate of 50mcg/h during 2 hours
Primary Outcome Measure Information:
Title
Change in HVPG
Time Frame
30 minutes, 1 hour and 2 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age: 18-75 years old.
Liver Cirrhosis
Portal hypertension
Stable disease in the absence of vasoactive agents
Signed informed consent form
Exclusion Criteria:
1. Patients on medications that can prolong QT interval 2. Patients with HCC not fulfilling Milan criteria for transplant 3. Grade II-IV hepatic encephalopathy 4. GI bleeding in the last 10 days 5. Child-Pugh C above 12 points 6. Bacterial infection in the last 10 days 7. HVPG <12mmHg 8. Plasma sodium <130mmol/l 9. Serum creatinine >2mg/dl 10. Serum bilirubin >5mg/dl 11. INR>2.5 12. Uncontrolled cardiovascular disease 13. HIV infection 14. Extra hepatic malignancies 15. Heart failure NYHA Grade III/IV, COPD GOLD>2 16. Morbid obesity 17. Coronary heart disease or intestinal ischemia 18. Pregnancy or breastfeeding
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Juan Carlos Garcia-Pagan, MD
Phone
+34932275400
Ext
5790
Email
jcgarcia@clinic.cat
Facility Information:
Facility Name
Hospital Clinic
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Hemodynamic Profile of Terlipressin and Octreotide in Patients With Cirrhosis and Portal Hypertension. A Randomised, Single Blinded Clinical Trial.
We'll reach out to this number within 24 hrs