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

NCT04353193 | Unknown Phase 4

• 2 other identifiers: INFUTER2019-004328-39
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Conditions

Liver Cirrhosis Portal

Outcome Measures

Primary Outcomes (1)

• Change in HVPG

  30 minutes, 1 hour and 2 hours

Study Arms (3)

Terlipressin IV bolus

EXPERIMENTAL

Terlipressin 1mg IV bolus

Drug: Terlipressin

Terlipressin IV continuous infusion

EXPERIMENTAL

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

Drug: Terlipressin

Octreotide IV bolus plus continuous infusion

EXPERIMENTAL

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

Drug: Octreotide

Interventions

Terlipressin DRUG

Terlipressin 1mg IV bolus

Terlipressin IV bolus

Octreotide DRUG

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

Octreotide IV bolus plus continuous infusion

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \. 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

Sponsors & Collaborators

• Juan A. Arnaiz: lead

Study Sites (1)

Hospital Clinic

Barcelona, 08036, Spain

Location

MeSH Terms

Interventions

Terlipressin; Octreotide

Intervention Hierarchy (Ancestors)

Lypressin; Vasopressins; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds

Central Study Contacts

Juan Carlos Garcia-Pagan, MD

CONTACT

+34932275400; jcgarcia@clinic.cat

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: single blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 16, 2020
• First Posted: April 20, 2020
• Study Start: June 1, 2020
• Primary Completion: February 1, 2022
• Study Completion: May 1, 2022
• Last Updated: April 20, 2020

Record last verified: 2020-04

Locations

ES (1)