NCT07304466 Effects of Terlipressin and Somatostatin on Portal Pressure in Patients Undergoing Living Donor Liver Transplantation
| NCT ID | NCT07304466 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Istanbul Medipol University Hospital |
| Condition | Liver Transplantation |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-12-29 |
| Primary Completion | 2027-03-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2025-12-29 with a primary completion date of 2027-03-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: 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 Criteria: * 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
Contact & Investigator
ayşe ince
PRINCIPAL INVESTIGATOR
Istanbul Medipol University Medipol Mega Hospital
Frequently Asked Questions
Who can join the NCT07304466 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Liver Transplantation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07304466 currently recruiting?
Yes, NCT07304466 is actively recruiting participants. Contact the research team at drayseince@gmail.com for enrollment information.
Where is the NCT07304466 trial being conducted?
This trial is being conducted at Istanbul, Turkey (Türkiye).
Who is sponsoring the NCT07304466 clinical trial?
NCT07304466 is sponsored by Istanbul Medipol University Hospital. The principal investigator is ayşe ince at Istanbul Medipol University Medipol Mega Hospital. The trial plans to enroll 50 participants.