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

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04353193
Acronym
INFUTER
Enrollment
36
Registered
2020-04-20
Start date
2020-06-30
Completion date
2022-05-31
Last updated
2020-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Cirrhosis Portal

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

Interventions

DRUGTerlipressin

Terlipressin 1mg IV bolus

DRUGOctreotide

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

Sponsors

Juan A. Arnaiz
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

single blind

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Change in HVPG30 minutes, 1 hour and 2 hours

Countries

Spain

Contacts

Primary ContactJuan Carlos Garcia-Pagan, MD
jcgarcia@clinic.cat+34932275400

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026