← Human Trials & Peer-Reviewed Studies
The Effect of Vasopressors on Cerebral Oxygentaion During Off Pump CABG
Plain-language guide to NCT04214145: not phased randomized trial of Vasopressin, 90 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT04214145
- Phase
- not phased
- Status
- completed
- Start
- 2020-01-07
- Completion (planned or actual)
- 2021-09-02
- Participants
- 90 (actual)
- Design
- randomized, quadruple-blind, treatment
- Conditions studied
- Cerebral Oxygen Saturation
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (not phased) is built around Vasopressin.
The purpose of this study is to analyze the changes in cerebral oxygen saturation during the use of three vasopressors, phenylephrine, norepinephrine, and vasopressin, which are currently used during coronary artery bypass grafting.
It had three arms (groups): Phenylephrine (experimental), Norepinephrine (experimental) and Vasopressin (experimental).
The registry classes the interventions as drug.
Who Took Part
90 actual participants took part.
It was open to people of any sex aged from 19 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Patients undergoing off pump coronary artery bypass.
The full record lists 1 inclusion and 6 exclusion criteria; among the exclusions: patient refusal; preoperative vasopressor use; preoperative mechanical circulatory support.
How the Study Was Run
The set-up was randomized, parallel-group and quadruple-blind.
Random assignment meant chance, not the researchers, decided who got Vasopressin and who got the comparison, which limits bias.
The Vasopressin group and the comparison group ran side by side rather than switching.
Neither the participants nor the staff measuring them knew who was on Vasopressin, so expectations could not easily colour the readings.
Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.
It started in 2020-01-07 with completion listed for 2021-09-02.
It ran at 1 site in South Korea.
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: Cerebral oxygen saturation (%) (time frame: during surgery).
It also tracked 14 secondary outcomes, for example blood pressure, heart rate, cardiac index, Total amount of infused drug, Input/output and Sublingual microscopy.
What This Means in Plain Language
Put simply, this is a not phased, randomized trial of Vasopressin in 90 people.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Vasopressin compound page, all human trials.
Our Notes on the Compound
Vasopressin: A 9-amino-acid hormone (antidiuretic hormone) that controls water balance and blood vessel tone; used in septic shock.
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.