Effects of Terlipressin and Somatostatin on Portal Pressure in Patients Undergoing Living Donor Liver Transplantation
Recruiting · NCT07304466 · Interventional (participants receive a specific treatment) · Lead sponsor: Istanbul Medipol University Hospital
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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
Where it is running
1 location listed.
- Istanbul Medipol University Medipol Mega Hospital - Istanbul, Bagcilar, Turkey (Türkiye)