The proposed study aims to investigate the hemodynamic effects of terlipressin and the time profile of these effects in patients with cirrhosis and portal hypertension when given as continuous infusion and compare it with that achieved when given as a bolus. In addition it also aims to evaluate the hemodynamic effects of octreotide in patients with cirrhosis and portal hypertension
Conditions
Interventions
Trade Name: Glypressin
Pharmaceutical Form: Solution for injection/infusion
INN or Proposed INN: TERLIPRESSIN
CAS Number: 14636-12-5
Concentration unit: mg milligram(s)
Concentration type: equal
Conce
Sponsors
Fundació Clínic per a la Recerca Biomèdica_FCRB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 18-75 years old. 2. Liver cirrhosis defined by standard clinical criteria, ultrasonographic findings and/or histology. Cirrhosis of any aetiology may be included. 3. Child-Pugh B patients or Child-Pugh C patients (up to 12 points). 4. Portal hypertension (defined as HVPG =12mmHg, confirmed during hepatic vein catheterisation) 5. Stable disease in the absence of vasoactive agents 6. Signed informed consent form Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 36 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 36
Exclusion criteria
Exclusion criteria: 1. Patients on medications that can prolong the QT interval, a prior history of QT prolongation or on any medication with a known risk of QT prolongation and Torsade de Pointes. 2. Morbid obesity 3. Prior history of cardiovascular disease including ischemic heart disease or intestinal ischemia. 4. Plasma sodium 5 mg/dL (85.5 µmol/L). 7. INR =2.5. 8. Bacterial infection within 10 days before study inclusion. 9. Gastrointestinal bleeding within 10 days before study inclusion. 10. Current overt hepatic encephalopathy, defined as grade II-IV hepatic encephalopathy according to the New-Haven classification. 11. Child-Pugh C patients (= 12 points). 12. Patients with active hepatocellular carcinoma or history of hepatocellular carcinoma that is in remission for less than six months for uninodular HCC or for less than 12 months for multinodular HCC within Milan criteria. (Patients with HCC not fulfilling Milan criteria for liver transplant) 13. HIV infection. 14. Patients with a history of significant extra hepatic disease with impaired short-term prognosis, including congestive heart failure New York Heart Association Grade III/IV, COPD GOLD >2, chronic kidney disease with serum creatinine >2mg/dL or under renal replacement therapy. 15. Patients with current extra hepatic malignancies including solid tumours and hematologic disorders. 16. Pregnancy or breastfeeding. 17. Patients included in other clinical trials in the month before inclusion. 18. Patients with mental incapacity, language barrier, bad social support or any other reason considered by the investigator precluding adequate understanding, cooperation or compliance in the study. 19. Refusal to give informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: Safety: To compare the safety of the three regimens with regard to cardiovascular and GI effects Exploratory Objective: To evaluate the hemodynamic and cardiopulmonary effects of octreotide and terlipressin in patients with cirrhosis and portal hypertension;Primary end point(s): Change in HVPG after 30 minutes, 1 hour and 2 hours of the administration of the three treatment regimens.;Timepoint(s) of evaluation of this end point: 30 minutes, 1 hour and 2 hours;Main Objective: To compare the reduction in HVPG caused by three different regimens at 30 minutes, 1 and 2 hours after its administration. Terlipressin at continuous infusion, terlipressin as a bolus, octreotide as a bolus followed by a continuous infusion. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety measured by changes in blood pressure and ECG, and adverse effects of the three treatment guidelines Changes in cardiopulmonary pressures and minute heart volume (blood pressure, heart rate, suprahepatic nailing and free pressure, nailed and free pulmonary blood pressure, right atrial pressure and cardiac output) after 30 minutes, 1 hour and 2 hours of administration of the three treatment guidelines;Timepoint(s) of evaluation of this end point: 30 minutes, 1 hour and 2 hours | — |
Countries
Spain
Contacts
Public ContactFCRB
Fundació Clínic per a la Recerca Biomèdica_FCRB
Outcome results
None listed