Hemodynamic Profile of Terlipressin and Octreotide in Patients With Cirrhosis and Portal Hypertension. A Randomised, Single Blinded Clinical Trial.

Phase 4

• Conditions: Liver Cirrhosis Portal
• Interventions: Drug: Octreotide; Drug: Terlipressin

• Registration Number: NCT04353193
• Lead Sponsor: Juan A. Arnaiz

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-04
• Study First Submitted: 2020-04-16
• Study First Submitted QC: 2020-04-16
• Last Update Submitted: 2020-04-16
• Study First Posted: 2020-04-20
• Last Update Posted: 2020-04-20
• Study Start: 2020-06
• Primary Completion: 2022-02
• Study Completion: 2022-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

1. Age: 18-75 years old.
2. Liver Cirrhosis
3. Portal hypertension
4. Stable disease in the absence of vasoactive agents
5. Signed informed consent form

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Octreotide IV bolus plus continuous infusion	Octreotide	Octreotide 50mcg IV bolus plus continuous infusion at a rate of 50mcg/h during 2 hours
Terlipressin IV bolus	Terlipressin	Terlipressin 1mg IV bolus
Terlipressin IV continuous infusion	Terlipressin	Terlipressin by IV continuous infusion at a rate of 2mg/day (max 4mg/day) during 2 hours

Primary Outcome Measures

Name	Time	Method
Change in HVPG	30 minutes, 1 hour and 2 hours

Trial Locations

Locations (1)

Hospital Clinic; 🇪🇸 Barcelona, Spain