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

Juan A. Arnaiz

Status and phase: Unknown; Phase 4

Conditions: Liver Cirrhosis Portal

Treatments: Drug: Terlipressin; Drug: Octreotide

Study type: Interventional

Funder types: Other

Identifiers

NCT04353193

INFUTER

2019-004328-39 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 36 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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36 participants in 3 patient groups

Terlipressin IV bolus

Experimental group

Description:

Terlipressin 1mg IV bolus

Treatment:

Drug: Terlipressin

Drug: Terlipressin

Terlipressin IV continuous infusion

Experimental group

Description:

Terlipressin by IV continuous infusion at a rate of 2mg/day (max 4mg/day) during 2 hours

Treatment:

Drug: Terlipressin

Drug: Terlipressin

Octreotide IV bolus plus continuous infusion

Experimental group

Description:

Octreotide 50mcg IV bolus plus continuous infusion at a rate of 50mcg/h during 2 hours

Treatment:

Drug: Octreotide