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

April 16, 2020 updated by: Juan A. Arnaiz
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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

36

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Juan Carlos Garcia-Pagan, MD
  • Phone Number: 5790 +34932275400
  • Email: jcgarcia@clinic.cat

Study Locations

  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in HVPG
Time Frame: 30 minutes, 1 hour and 2 hours
30 minutes, 1 hour and 2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Juan A. Arnaiz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2020

Primary Completion (Anticipated)

February 1, 2022

Study Completion (Anticipated)

May 1, 2022

Study Registration Dates

First Submitted

April 16, 2020

First Submitted That Met QC Criteria

April 16, 2020

First Posted (Actual)

April 20, 2020

Study Record Updates

Last Update Posted (Actual)

April 20, 2020

Last Update Submitted That Met QC Criteria

April 16, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INFUTER
  • 2019-004328-39 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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