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Trial · Interventional

Status unknownPhase 4Registry data

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

Short name INFUTER

NCTNCT04353193 (opens ClinicalTrials.gov in a new tab)Other idINFUTEROther id2019-004328-39Other id2019
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Status unknown
Phase
Phase 4
Enrollment
36 participants (estimated)
Sponsor
Juan A. Arnaiz · Other
Design
Randomized · Single masking
Countries
1 country

Spain

Start
Jun 2020 (estimated)
Primary completion
Feb 2022 (estimated)
Completion
May 2022 (estimated)
First posted
20 Apr 2020
Last update posted
20 Apr 2020
Conditions
Liver Cirrhosis Portal

Timeline

1 trial

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2020202120222023
  1. Ph 4

    INFUTER

    NCT04353193

    est. Jun 2020 to est. May 2022

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • TerlipressinDrug
  • TerlipressinDrug
  • OctreotideDrug

Arms3

  • Experimental

    Terlipressin IV bolus

    Terlipressin 1mg IV bolus

  • Experimental

    Terlipressin IV continuous infusion

    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

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in HVPG

    Time frame · 30 minutes, 1 hour and 2 hours

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 75 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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