Status:
UNKNOWN
Hemodynamic Profile of Terlipressin and Octreotide in Patients With Cirrhosis and Portal Hypertension. A Randomised, Single Blinded Clinical Trial.
Lead Sponsor:
Juan A. Arnaiz
Conditions:
Liver Cirrhosis Portal
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
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
Eligibility Criteria
Inclusion
- Age: 18-75 years old.
- Liver Cirrhosis
- Portal hypertension
- Stable disease in the absence of vasoactive agents
- Signed informed consent form
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2022
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT04353193
Start Date
June 1 2020
End Date
May 1 2022
Last Update
April 20 2020
Active Locations (1)
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1
Hospital Clinic
Barcelona, Spain, 08036