Methylene Blue and Ozone in Early Sepsis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2017-04-30

Brief Summary

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effects of methylene blue and ozone O3 therapy effects in early sepsis management , and their implications upon outcome

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Detailed Description

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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 . our study collaborate both methylene blue and Ozone in early sepsis management , and we will evaluate the global medical progress , ICU stay , Morbidity and mortality

Conditions

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Sepsis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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M methylene blue and ozone

intravenous methylene blue and blood mixed with ozone ozone injection in early sepsis patients

Group Type ACTIVE_COMPARATOR

methylene blue

Intervention Type DRUG

ozone

Intervention Type DRUG

P Placebo

saline and oxygen mixed blood injection in early sepsis patients

Group Type PLACEBO_COMPARATOR

saline infusion

Intervention Type OTHER

oxygen

Intervention Type OTHER

Interventions

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methylene blue

Intervention Type DRUG

ozone

Intervention Type DRUG

saline infusion

Intervention Type OTHER

oxygen

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* early sepsis Adults patients

Exclusion Criteria

* cardiac problems Glucose-6-Phosphate-Dehydrogenase Insufficiency Ozone Allergy Recent Myocardial Infarction Active Hyperthyroidism Thrombocytopenia Pregnancy Contraindications

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No