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Methylene Blue and Ozone in Early Sepsis
Plain-language guide to NCT02910765: phase 4 randomized trial of Methylene blue (non-peptide stack partner), 40 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02910765
- Phase
- phase 4
- Status
- status unknown
- Start
- 2016-10
- Completion (planned or actual)
- 2017-03
- Participants
- 40 (estimated)
- Design
- randomized, double-blind, supportive_care
- Conditions studied
- Sepsis
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 4 trial tested Methylene blue (non-peptide stack partner).
Effects of methylene blue and ozone O3 therapy effects in early sepsis management , and their implications upon outcome.
It had two arms (groups): M methylene blue and ozone (active comparator) and P Placebo (placebo comparator).
Intravenous methylene blue and blood mixed with ozone ozone injection in early sepsis patients.
Saline and oxygen mixed blood injection in early sepsis patients.
The registry classes the interventions as drug and other.
More on the Plan
Effects of methylene blue on inducible nitric oxide messenger RNA transcription and protein expression are well evident in vasoplegia ,and septic shock .
In the same time , ozone O3 therapy is also valuable in immune-modulation in multiple pathologies . their study collaborate both methylene blue and Ozone in early sepsis management , and the researchers will evaluate the global medical progress , ICU stay , Morbidity and mortality.
Who Took Part
Enrollment: 40 planned participants were the target.
It was open to people of any sex aged from 18 years up to 40 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Early sepsis Adults patients.
The full record lists 1 inclusion and 1 exclusion criteria; among the exclusions: cardiac problems glucose-6-phosphate-dehydrogenase insufficiency ozone allergy recent myocardial infarction active hyperthyroidism thrombocytopenia pregnancy contraindications.
How the Study Was Run
Design: randomized, parallel-group and double-blind.
The participants were allocated by chance, so the Methylene blue (non-peptide stack partner) group and the comparison group should start out alike.
The Methylene blue (non-peptide stack partner) group and the comparison group ran side by side rather than switching.
As a double-blind Methylene blue (non-peptide stack partner) study, the assignments were hidden from both participants and investigators until the end.
Those kept unaware of assignments: care provider and outcomes assessor.
It started in 2016-10 with completion listed for 2017-03.
Its stated primary purpose is supportive care.
What Was Measured
The main thing measured (primary outcome): APACHE score (time frame: 7 days).
It also tracked 1 secondary outcome, for example ICU stay.
What This Means in Plain Language
Put simply, this is a phase 4, randomized trial of Methylene blue (non-peptide stack partner) in 40 people.
Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Methylene blue (non-peptide stack partner) compound page, all human trials.
Our Notes on the Compound
Methylene blue (non-peptide stack partner): Described as an electron cycler, not just a dye.
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.