About this trial
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
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Allergy to any of the medications to be used
Portal vein thrombosis
Being treated with terlipressin with a diagnosis of hepatorenal syndrome
Portopulmonary hypertension
Trial design
Parallel
Treatments tested in this trial
Somatostatin
DrugFollowing 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.
Terlipressin
DrugFollowing 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.
Treatment groups
Trial outcomes
Primary outcomes
Decrease in portal pressure by 20% from the baseline
The proportion of patients achieving a ≥20% reduction in portal pressure from baseline at any of the predefined intraoperative assessment timepoints will be recorded.
Secondary outcomes
Change in Portal Pressure (mmHg)
The change in portal pressure from baseline will be recorded at predefined intraoperative timepoints using direct portal pressure measurements. The change will be expressed in millimetres of mercury (mmHg).
Amount of bleeding (milliliters)
Total intraoperative blood loss will be measured in millilitres.
Perioperative Blood Transfusion (Units)
The total number of blood units transfused during the perioperative period will be recorded.
Hepatic Artery Peak Systolic Flow (cm/s)
The peak systolic flow of the hepatic artery will be measured by intraoperative Doppler ultrasound after completion of the arterial anastomosis.
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