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Effects of Terlipressin on Renal Perfusion in Patients With Septic Shock
Plain-language guide to NCT04948372: not phased randomized trial of Terlipressin, 22 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT04948372
- Phase
- not phased
- Status
- completed
- Start
- 2019-09-01
- Completion (planned or actual)
- 2020-05-31
- Participants
- 22 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Septic Shock
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this not phased trial, researchers set out to test Terlipressin.
It had two arms (groups): The terlipressin group (experimental) and The usual care group (placebo comparator).
Patients in the usual care group were treated with standard care.
The registry classes the interventions as drug.
More on the Plan
Renal perfusion was monitored by renal contrast-enhanced ultrasound.
The primary outcome was peak intensity (renal perfusion parameter) at 24 hours after enrollment.
Who Took Part
22 actual participants took part.
It was open to people of any sex aged from 18 years up to 85 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Adult septic shock patients (age≥18 years old).
The full record lists 2 inclusion and 6 exclusion criteria; among the exclusions: age older than 85 years; serum creatinine more than 177 μmol/l; acute myocardial ischemia.
How the Study Was Run
It was run as a randomized, parallel-group and open-label 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.
Being open-label, the Terlipressin study did not mask who received what.
It started in 2019-09-01 with completion listed for 2020-05-31.
It ran at 1 site in China.
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Peak intensity (time frame: 24 hours after enrollment).
It also tracked 2 secondary outcomes, for example urine output, mL and The incidence of acute kidney injury.
What This Means in Plain Language
Put simply, this is a not phased, randomized trial of Terlipressin in 22 people.
Its size is small, so on its own it can only give an early look.
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.