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Does Terlipressin Improve Renal Outcome After Liver Surgery
Plain-language guide to NCT02368249: phase 2 randomized trial of Terlipressin. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02368249
- Phase
- phase 2
- Status
- withdrawn
- Start
- 2020-01
- Completion (planned or actual)
- 2025-02
- Participants
- n/a (actual)
- Design
- randomized, double-blind, prevention
- Conditions studied
- Kidney Failure
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 2 trial tested Terlipressin.
Therefore the investigators are planning to conduct a double-blinded randomized control trial.
It had two arms (groups): Control Group (placebo comparator) and Terlipressin Group (experimental).
Patients receiving post-operative placebo (Ringer lactate solution) treatment to preserve the renal function.
Patients receiving a post-operative intravenous terlipressin treatment in association with human albumin to preserve the renal function.
The registry classes the interventions as drug.
Who 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.
The full record lists 1 inclusion and 4 exclusion criteria; among the exclusions: \< 18 years; liver cirrhosis; coronary insufficiency with st-elevation or st-depression in the - - intra-operative ecg as signs of an acute coronary syndrome.
How the Study Was Run
It was run as a randomized, single-group and double-blind study.
Because people in this Terlipressin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.
Blinding on both sides kept the participants and researchers unaware of who received Terlipressin.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
Those kept unaware of assignments: participant and investigator.
It started in 2020-01 with completion listed for 2025-02.
It ran at 1 site in Switzerland.
Its stated primary purpose is prevention.
What Was Measured
The main thing measured (primary outcome): serum creatinine peak level within 48 hours post-operative (time frame: within 48 hours post-operative).
It also tracked 6 secondary outcomes, for example the urinary output/24h, Need for hemofiltration and/or hemodialysis, Morbidity & mortality, Liver function, length of hospital stay and length of ICU stay.
What This Means in Plain Language
Put simply, this is a phase 2, randomized trial of Terlipressin in people.
It was withdrawn before enrolling anyone; 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.