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Methylene Blue and Ozone in Early Sepsis

Primary Purpose

Sepsis

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
methylene blue
ozone
saline infusion
oxygen
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Sepsis

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    M methylene blue and ozone

    P Placebo

    Arm Description

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

    saline and oxygen mixed blood injection in early sepsis patients

    Outcomes

    Primary Outcome Measures

    APACHE score

    Secondary Outcome Measures

    ICU stay

    Full Information

    First Posted
    September 20, 2016
    Last Updated
    September 20, 2016
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02910765
    Brief Title
    Methylene Blue and Ozone in Early Sepsis
    Official Title
    Methylene Blue and Ozone in Early Sepsis , a Randomized Double Blind Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 2016 (undefined)
    Primary Completion Date
    March 2017 (Anticipated)
    Study Completion Date
    April 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sepsis

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Care ProviderOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    M methylene blue and ozone
    Arm Type
    Active Comparator
    Arm Description
    intravenous methylene blue and blood mixed with ozone ozone injection in early sepsis patients
    Arm Title
    P Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    saline and oxygen mixed blood injection in early sepsis patients
    Intervention Type
    Drug
    Intervention Name(s)
    methylene blue
    Intervention Type
    Drug
    Intervention Name(s)
    ozone
    Intervention Type
    Other
    Intervention Name(s)
    saline infusion
    Intervention Type
    Other
    Intervention Name(s)
    oxygen
    Primary Outcome Measure Information:
    Title
    APACHE score
    Time Frame
    7 days
    Secondary Outcome Measure Information:
    Title
    ICU stay
    Time Frame
    30 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Emad Zarief K. Said, MD
    Phone
    00201007046058
    Email
    emadzarief@yahoo.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Abdelraheem Elawamy, MD
    Phone
    00201000032655
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Emad Zarief K Said, MD
    Organizational Affiliation
    Assiut University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Methylene Blue and Ozone in Early Sepsis

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