Current partner codePEPTIDESDE
NCT04353193·Phase 4·INTERVENTIONAL

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

Status

Unknown

Phase

Phase 4

Enrollment

36

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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

Treatment arms and agents.

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

DRUG

Octreotide

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

Timeline

From registration to results.

  1. First posted

    Apr 20, 2020

  2. Study start

    Jun 2020

  3. Primary completion

    Feb 2022

  4. Study completion

    May 2022

  5. Results posted

    Not reported

  6. Registry updated

    Apr 20, 2020

Outcomes

What the study measures.

Primary outcomes

Change in HVPG

Time frame · 30 minutes, 1 hour and 2 hours

Secondary outcomes

Not reported in the indexed record.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
75 Years
Sex
ALL
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

Study locations

1 registered sites.

Spain. Showing up to 24 locations stored in the fast local snapshot.

Hospital Clinic

Barcelona, Spain

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Terlipressin.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.