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Effects of Terlipressin and Somatostatin on Portal Pressure in Patients Undergoing Living Donor Liver Transplantation
Plain-language guide to NCT07304466: not phased randomized trial of Somatostatin and Terlipressin, 50 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT07304466
- Phase
- not phased
- Status
- recruiting participants
- Start
- 2025-12-29
- Completion (planned or actual)
- 2027-03-15
- Participants
- 50 (estimated)
- Design
- randomized, double-blind, treatment
- Conditions studied
- Liver Transplantation; Portal Hypertension
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this not phased trial, researchers set out to test Somatostatin and Terlipressin.
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.
It will also compare the effects of these drugs on hemodynamics, bleeding, and transfusion requirements.
It had two arms (groups): Group Somatostatin (SS) (active comparator) and Group Terlipressin (TR) (active comparator).
Somatostatin will be given.
Terlipressin will be given.
The registry classes the interventions as drug.
More on the Plan
By lowering portal pressure and exerting favorable systemic effects, it is often used intraoperatively in patients with impaired renal function.
Following baseline portal pressure measurement from the portal vein (PVP0), patients will receive treatment according to their study group.
Once the hepatic and portal vein anastomoses are completed and graft reperfusion is achieved, the third portal pressure measurement will be taken (PVP2), and right after completion of the arterial anastomosis, the fourth portal pressure measurement will be performed (PVP3).
If performed, this intervention will be recorded, and subsequent measurements will be repeated (PVP4) Intraoperative ultrasound routinely performed by radiology will be used to measure arterial (peak systolic velocity, resistive index, acceleration time) and portal (flow volume) flow parameters, which will be documented.
Who Took Part
50 planned participants were the target.
It was open to people of any sex aged from 18 years up to 70 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
The full record lists 0 inclusion and 10 exclusion criteria; among the exclusions: allergy to any of the medications to be used; portal vein thrombosis; being treated with terlipressin with a diagnosis of hepatorenal syndrome.
How the Study Was Run
It was run as a randomized, parallel-group and double-blind study.
Because people in this Somatostatin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.
Groups ran in parallel: each of the participants stayed in one arm throughout.
As a double-blind Somatostatin study, the assignments were hidden from both participants and investigators until the end.
Those kept unaware of assignments: participant and outcomes assessor.
It started in 2025-12-29 with completion listed for 2027-03-15.
It ran at 1 site in Turkey (Türkiye).
Its stated primary purpose is treatment.
What Was Measured
It also tracked 7 secondary outcomes, for example Change in Portal Pressure (mmHg), Amount of bleeding (milliliters), Perioperative Blood Transfusion (Units), Hepatic Artery Peak Systolic Flow (cm/s), Portal Vein Flow Velocity (cm/s) and Hepatic artery acceleration time (AT).
What This Means in Plain Language
Put simply, this is a not phased, randomized trial of Somatostatin and Terlipressin in 50 people.
It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Somatostatin compound page and the Terlipressin compound page, all human trials.
Our Notes on the Compounds
Somatostatin: A 14-amino-acid hormone that switches off the release of several other hormones, including growth hormone and insulin.
Terlipressin: A synthetic vasopressin analog (Terlivaz) used for kidney failure in advanced liver disease and for variceal bleeding.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.