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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-30

Study Completion Date

2022-05-31

Brief Summary

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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

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Detailed Description

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Conditions

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Liver Cirrhosis Portal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

single blind

Study Groups

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Octreotide IV bolus plus continuous infusion

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

Group Type EXPERIMENTAL

Octreotide

Intervention Type DRUG

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

Terlipressin IV bolus

Terlipressin 1mg IV bolus

Group Type EXPERIMENTAL

Terlipressin

Intervention Type DRUG

Terlipressin 1mg IV bolus

Terlipressin IV continuous infusion

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

Group Type EXPERIMENTAL

Terlipressin

Intervention Type DRUG

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

Interventions

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Terlipressin

Terlipressin 1mg IV bolus

Intervention Type DRUG

Terlipressin

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

Intervention Type DRUG

Octreotide

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No