Methylene Blue and Ozone in Early Sepsis

Assiut University

Status and phase: Unknown; Phase 4

Conditions: Sepsis

Treatments: Drug: methylene blue; Drug: ozone; Other: saline infusion; Other: oxygen

Study type: Interventional

Funder types: Other

Identifiers

NCT02910765

IRB00009906

Details and patient eligibility

About

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

Full 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

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 40 years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

40 participants in 2 patient groups, including a placebo group

M methylene blue and ozone

Active Comparator group

Description:

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

Treatment:

Drug: ozone

Drug: methylene blue

P Placebo

Placebo Comparator group

Description:

saline and oxygen mixed blood injection in early sepsis patients

Treatment:

Other: saline infusion

Other: oxygen