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NCT02910765 Clinical Trial

Methylene Blue and Ozone in Early Sepsis

Sepsis Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT02910765
Other study ID # IRB00009906
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received September 20, 2016
Last updated September 20, 2016
Start date October 2016
Est. completion date April 2017

Study information
Verified date September 2016
Source Assiut University
Contact Emad Zarief K. Said, MD
Phone 00201007046058
Email emadzarief@yahoo.com
Is FDA regulated No
Health authority Egypt: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 40
Est. completion date April 2017
Est. primary completion date March 2017
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 40 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Intervention

Drug:
• methylene blue

• ozone

Other:
• saline infusion

• oxygen

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Assiut University

Outcome
Type Measure Description Time frame Safety issue
Primary APACHE score 7 days Yes
Secondary ICU stay 30 days No
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