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The Effect of Terlipressin on Intesitnal Function in Septic Shock Patients
Plain-language guide to NCT02306239: not phased randomized trial of Terlipressin, 40 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02306239
- Phase
- not phased
- Status
- status unknown
- Start
- 2014-12
- Completion (planned or actual)
- 2015-08
- Participants
- 40 (estimated)
- Design
- randomized, triple-blind, treatment
- Conditions studied
- Terlipressin; Septic Shock
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered not phased trial tested Terlipressin.
Terlipressin becomes a vasopressin for septic shock.
But some studies found it may lead to severe intesitnal complications such as intestinal ischemia.
The investigators study was designed to find the effect of terlipressin on intestinal function in septic shock patients.
It had two arms (groups): norepinephrine (active comparator) and terlipressin (experimental).
Patients received norepinephrine.
Patients received terlipressin.
The registry classes the interventions as drug.
Who Took Part
Enrollment: 40 planned participants were the target.
It was open to people of any sex aged from 18 years up to 80 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
The full record lists 1 inclusion and 2 exclusion criteria; among the exclusions: shock due to other reasons; diagnosited intesitinal ischemia.
How the Study Was Run
It was run as a randomized, parallel-group and triple-blind study.
The participants were allocated by chance, so the Terlipressin group and the comparison group should start out alike.
Groups ran in parallel: each of the participants stayed in one arm throughout.
As a double-blind Terlipressin study, the assignments were hidden from both participants and investigators until the end.
Those kept unaware of assignments: care provider, investigator and outcomes assessor.
It started in 2014-12 with completion listed for 2015-08.
It ran at 1 site in China.
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): intestinal function assessed by abdominal distension, intestinal bleeding, peritonitis, plasma DAO level, enteral nutrition (time frame: 7 days).
What This Means in Plain Language
Put simply, this is a not phased, randomized trial of Terlipressin in 40 people.
Its status is unknown; 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.