NCT02910765

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at below P25 for phase_4 sepsis

Timeline
Completed

Started Oct 2016

Shorter than P25 for phase_4 sepsis

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 20, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 22, 2016

Completed
9 days until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

September 22, 2016

Status Verified

September 1, 2016

Enrollment Period

5 months

First QC Date

September 20, 2016

Last Update Submit

September 20, 2016

Conditions

Sepsis

Outcome Measures

Primary Outcomes (1)

  • APACHE score

    7 days

Secondary Outcomes (1)

  • ICU stay

    30 days

Study Arms (2)

M methylene blue and ozone

ACTIVE COMPARATOR

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

Drug: methylene blueDrug: ozone

P Placebo

PLACEBO COMPARATOR

saline and oxygen mixed blood injection in early sepsis patients

Other: saline infusionOther: oxygen

Interventions

methylene blueDRUG
M methylene blue and ozone
ozoneDRUG
M methylene blue and ozone
saline infusionOTHER
P Placebo
oxygenOTHER
P Placebo

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • early sepsis Adults patients

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Sepsis

Interventions

Methylene BlueOzoneOxygen

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PhenothiazinesSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsGasesInorganic ChemicalsChalcogensElements

Study Officials

  • Emad Zarief K Said, MD

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Emad Zarief K. Said, MD

CONTACT

00201007046058emadzarief@yahoo.com

Abdelraheem Elawamy, MD

CONTACT

00201000032655

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Anesthesia and critical care Medicine

Study Record Dates

First Submitted

September 20, 2016

First Posted

September 22, 2016

Study Start

October 1, 2016

Primary Completion

March 1, 2017

Study Completion

April 1, 2017

Last Updated

September 22, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share