Methylene Blue and Ozone in Early Sepsis

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

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

Study Overview

• Status: Unknown
• Conditions: Sepsis
• Intervention / Treatment: Drug: methylene blue; Drug: ozone; Other: saline infusion; Other: oxygen

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Emad Zarief K. Said, MD; Phone Number: 00201007046058; Email: emadzarief@yahoo.com
• Study Contact Backup: Name: Abdelraheem Elawamy, MD; Phone Number: 00201000032655

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
APACHE score	7 days

Secondary Outcome Measures

Outcome Measure	Time Frame
ICU stay	30 days

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Principal Investigator: Emad Zarief K Said, MD, Assiut University

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (ANTICIPATED): March 1, 2017
• Study Completion (ANTICIPATED): April 1, 2017

Study Registration Dates

• First Submitted: September 20, 2016
• First Submitted That Met QC Criteria: September 20, 2016
• First Posted (ESTIMATE): September 22, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): September 22, 2016
• Last Update Submitted That Met QC Criteria: September 20, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Toxemia; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Methylene Blue
• Other Study ID Numbers: IRB00009906

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO