Methylene Blue and Ozone in Early Sepsis | NCT02910765

Studies
Methylene Blue and Ozone in Early Sepsis

NCT02910765

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Sep 22, 2016Estimated

Enrollment

40Estimated

Phase

Phase 4

Conditions

Sepsis

Interventions

methylene blue
ozone
saline infusion
oxygen

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2016

Primary Completion Date

Mar 2017Estimated

Completion Date

Apr 2017Estimated

First Submitted Date

Sep 20, 2016

First Submission Date that Met QC Criteria

Sep 20, 2016

First Posted Date

Sep 22, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 20, 2016

Last Update Posted Date

Sep 22, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

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

Lead Sponsor

Assiut UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
M methylene blue and ozone	Active Comparator	intravenous methylene blue and blood mixed with ozone ozone injection in early sepsis patients	Drug: methylene blue Drug: ozone
P Placebo	Placebo Comparator	saline and oxygen mixed blood injection in early sepsis patients	Other: saline infusion Other: oxygen

Interventions

Name	Type	Description	Arm Group Labels	Other Names
methylene blue	Drug		M methylene blue and ozone
ozone

Measure	Description	Time Frame
APACHE score		7 days

Measure	Description	Time Frame
ICU stay		30 days

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Emad Zarief K. Said, MD	Contact	00201007046058		emadzarief@yahoo.com
Abdelraheem Elawamy, MD	Contact	00201000032655

Overall Officials

Name	Affiliation	Role
Emad Zarief K Said, MD	Assiut University	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D018805	Sepsis

Ancestor Terms

ID	Term
D007239	Infections
D018746	Systemic Inflammatory Response Syndrome
D007249	Inflammation
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008751	Methylene Blue
D010126	Ozone
D010100	Oxygen

Ancestor Terms

ID	Term
D010640	Phenothiazines
D013457	Sulfur Compounds
D009930	Organic Chemicals
D006575	Heterocyclic Compounds, 3-Ring

Browse Leaves

Not provided

Browse Branches

Not provided