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Effect of Terlipressin Infusion on Systemic and Hepatic Hemodynamics During Hepatobiliary Surgery
Plain-language guide to NCT02718599: phase 2 randomized trial of Terlipressin, 50 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02718599
- Phase
- phase 2
- Status
- completed
- Start
- 2016-04
- Completion (planned or actual)
- 2017-07
- Participants
- 50 (actual)
- Design
- randomized, double-blind, treatment
- Conditions studied
- Hemodynamics, Liver, Terlipressin
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this phase 2 trial, researchers set out to test Terlipressin.
To evaluate the effect of terlipressin infusion on systemic and hepatic hemodynamics during hepatobiliary surgery.
It had two arms (groups): Terlipressin (active comparator) and CONTROL (placebo comparator).
The registry classes the interventions as drug.
Who Took Part
The registry lists 50 actual participants took part.
It was open to people of any sex aged from 18 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Age \> 18 years. ASA (American Society of Anesthesiologists) Classification( Class I-II). Patients undergoing major elective hepatobiliary surgery.
The full record lists 4 inclusion and 9 exclusion criteria; among the exclusions: severe liver dysfunction (child- turcotte -pugh grade c); severe aortic regurgitation, severe mitral regurgitation, heart failure; symptomatic coronary heart disease.
How the Study Was Run
The set-up was randomized, parallel-group and double-blind.
Random assignment meant chance, not the researchers, decided who got Terlipressin and who got the comparison, which limits bias.
Groups ran in parallel: each of the participants stayed in one arm throughout.
Blinding on both sides kept the participants and researchers unaware of who received Terlipressin.
Those kept unaware of assignments: participant and investigator.
It started in 2016-04 with completion listed for 2017-07.
It ran at 1 site in Egypt.
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: portal pressure changes (time frame: intraoperative period).
It also tracked 3 secondary outcomes, for example Effect on systemic vascular resistance, Renal impairment and Blood units transfused.
What This Means in Plain Language
Put simply, this is a phase 2, randomized trial of Terlipressin in 50 people.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Terlipressin compound page, all human trials.
Our Notes on the Compound
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.