RecruitingNot ApplicableNCT07304466

Effects of Terlipressin and Somatostatin on Portal Pressure in Patients Undergoing Living Donor Liver Transplantation

Comparison of the Effects of Terlipressin and Somatostatin on Portal Pressure in Patients Undergoing Living Donor Liver Transplantation


Sponsor

Istanbul Medipol University Hospital

Enrollment

50 participants

Start Date

Dec 29, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to compare the effects of somatostatin and terlipressin on lowering portal pressure in patients with portal hypertension undergoing liver transplantation, and to investigate whether there are differences in clinical outcomes between the two drugs. The study will evaluate the decrease in portal pressure from baseline following drug administration at defined time points. It will also compare the effects of these drugs on hemodynamics, bleeding, and transfusion requirements. After baseline intraoperative direct portal pressure measurement, a bolus dose of the study drug will be administered, followed by continuous intravenous infusion intraoperatively and for 24 hours postoperatively. Direct portal pressure will be measured again 5 minutes after the bolus dose, after the portal vein anastomosis, after the hepatic artery anastomosis, and, if performed after splenic artery ligation. Hemodynamic parameters will be recorded, and the drugs will be compared in terms of their intraoperative hemodynamic effects. As elevated portal pressure is associated with increased bleeding, intraoperative blood loss and transfusion needs will also be assessed between the groups. Patients will be followed for 7 days postoperatively for clinical and laboratory outcomes.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria1

  • Patients scheduled for right lobe living donor liver transplantation with clinically significant portal hypertension (esophageal varices, thrombocytopenia (<100,000), ascites, encephalopathy; Child-Turcotte-Pugh class B-C)

Exclusion Criteria10

  • Allergy to any of the medications to be used
  • Portal vein thrombosis
  • Being treated with terlipressin with a diagnosis of hepatorenal syndrome
  • Portopulmonary hypertension
  • Acute on chronic liver failure
  • Chronic renal failure (glomerular filtration rate ≤ 30%)
  • Myocardial ischemia
  • Uncontrolled hypertension
  • Arrhythmia
  • Multiple solid organ transplantation

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Interventions

DRUGSomatostatin

Following baseline portal pressure measurement from the portal vein (25 Gauge intracath, Bıçakçılar®) (PVP0), somatostatin (Somatex®) will be administered as a 250 mcg bolus over 2 minutes, followed by a continuous infusion at 2.5 mcg/kg/hour. Direct portal measurements will be done at the time points explained in the study description. Intraoperative ultrasound (GE Healthcare®, linear probe) will be used to record arterial and portal flow parameters. Hemodynamic data will be collected during all measurements. The study drug will be infused continuously for at least 24 hours.

DRUGTerlipressin

Following baseline portal pressure measurement from the portal vein (25 Gauge intracath, Bıçakçılar®) (PVP0), terlipressin (Glypressin®) will be administered as a 1 mg bolus over 2 minutes, followed by a continuous infusion at 2 mcg/kg/hour. Direct portal measurements will be done at the time points explained in the study description. Intraoperative ultrasound (GE Healthcare®, linear probe) will be used to record arterial and portal flow parameters. Hemodynamic data will be collected during all measurements. The study drug will be infused continuously for at least 24 hours, and up to 5 days if portal pressure remains elevated.


Locations(1)

Istanbul Medipol University Medipol Mega Hospital

Istanbul, Bagcilar, Turkey (Türkiye)

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NCT07304466


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