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

Liver Cirrhosis Portal Clinical Trial

— INFUTER  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04353193
• Other study ID #: INFUTER
• Secondary ID: 2019-004328-39
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: June 2020
• Est. completion date: May 2022

Study information

• Verified date: April 2020
• Source: Hospital Clinic of Barcelona
• Contact: Juan Carlos Garcia-Pagan, MD
• Phone: +34932275400
• Email: jcgarcia[@]clinic.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 36
• Est. completion date: May 2022
• Est. primary completion date: February 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Fibrosis
• Hypertension
• Hypertension, Portal
• Liver Cirrhosis
• Liver Cirrhosis Portal

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital Clinic	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Juan A. Arnaiz

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HVPG		30 minutes, 1 hour and 2 hours