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Methylene Blue vs Cyanokit for Intraoperative Vasoplegic Syndrome in Liver Transplant Patients
Plain-language guide to NCT04054999: phase 4 randomized trial of Methylene blue (non-peptide stack partner) and Cyanocobalamin (Vitamin B12), 19 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT04054999
- Phase
- phase 4
- Status
- completed
- Start
- 2019-11-30
- Completion (planned or actual)
- 2023-02-27
- Participants
- 19 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Vasoplegic Syndrome; Liver Transplant; Complications
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
In this phase 4 trial, researchers set out to test Methylene blue (non-peptide stack partner) and Cyanocobalamin (Vitamin B12).
It had two arms (groups): Cyanokit (experimental) and Methylene Blue (active comparator).
The registry classes the interventions as drug.
Who Took Part
Enrollment: 19 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: Patients scheduled to undergo liver transplantation. SVR lower than 500 dynes-sec/cm-5 intraoperatively (this criterion must be met after consent intraoperatively).
The full record lists 3 inclusion and 0 exclusion criteria.
How the Study Was Run
The set-up was randomized, parallel-group and open-label.
The participants were allocated by chance, so the Methylene blue (non-peptide stack partner) 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 Methylene blue (non-peptide stack partner) study did not mask who received what.
It started in 2019-11-30 with completion listed for 2023-02-27.
It ran at 1 site in United States.
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Systemic Vascular Resistance (SVR) (time frame: 15, 30, 60, 90 and 120 minutes after initiation of treatment). Systolic Blood Pressure (time frame: 15, 30, 60, 90 and 120 minutes after initiation of treatment). Diastolic Blood Pressure (time frame: 15, 30, 60, 90 and 120 minutes after initiation of treatment).
It also tracked 3 secondary outcomes, for example Post-operative Intensive Care Unit (ICU) Length of Stay, Hospital Length of Stay and Post-operative Complications.
What This Means in Plain Language
Put simply, this is a phase 4, randomized trial of Methylene blue (non-peptide stack partner) and Cyanocobalamin (Vitamin B12) in 19 people.
Its size is small, so on its own it can only give an early look.
The trial is marked completed; results are posted on the registry, and this page does not restate them.
More context: the Methylene blue (non-peptide stack partner) compound page and the Cyanocobalamin (Vitamin B12) compound page, all human trials.
Our Notes on the Compounds
Methylene blue (non-peptide stack partner): Described as an electron cycler, not just a dye.
Cyanocobalamin (Vitamin B12): A synthetic form of vitamin B12 (cobalamin), an essential nutrient for DNA synthesis, red blood cell formation and neurological function.
Related Pages
- Methylene blue (non-peptide stack partner) in the library
- Cyanocobalamin (Vitamin B12) in the library
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.