Methylene Blue and Ozone in Early Sepsis

Sponsor

Assiut University (Other)

Overall Status

Unknown status

CT.gov ID

NCT02910765

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Sepsis	Drug: methylene blue Drug: ozone Other: saline infusion Other: oxygen	Phase 4

Detailed Description

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Care Provider, Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

Methylene Blue and Ozone in Early Sepsis , a Randomized Double Blind Trial

Study Start Date :

Oct 1, 2016

Anticipated Primary Completion Date :

Mar 1, 2017

Anticipated Study Completion Date :

Apr 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: M methylene blue and ozone intravenous methylene blue and blood mixed with ozone ozone injection in early sepsis patients	Drug: methylene blue Drug: ozone
Placebo Comparator: P Placebo saline and oxygen mixed blood injection in early sepsis patients	Other: saline infusion Other: oxygen

Arm

Intervention/Treatment

Active Comparator: M methylene blue and ozone

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

Drug: methylene blue

Drug: ozone

Placebo Comparator: P Placebo

saline and oxygen mixed blood injection in early sepsis patients

Other: saline infusion

Other: oxygen

Outcome Measures

Primary Outcome Measures

APACHE score [7 days]

Secondary Outcome Measures

ICU stay [30 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Assiut University

Investigators

Principal Investigator: Emad Zarief K Said, MD, Assiut University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Emad Zarief , MD, Lecturer of Anesthesia and critical care Medicine, Assiut University

ClinicalTrials.gov Identifier:

NCT02910765

Other Study ID Numbers:

IRB00009906

First Posted:

Sep 22, 2016

Last Update Posted:

Sep 22, 2016

Last Verified:

Sep 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Sepsis

Toxemia

Methylene Blue

Study Results

No Results Posted as of Sep 22, 2016