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临床试验/NCT02910765
NCT02910765Unknown4 期

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

Assiut University0 个研究点目标入组 40 人开始时间: 2016年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
40
主要终点
APACHE score

研究概览

简要总结

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

详细描述

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • early sepsis Adults patients

排除标准

  • cardiac problems Glucose-6-Phosphate-Dehydrogenase Insufficiency Ozone Allergy Recent Myocardial Infarction Active Hyperthyroidism Thrombocytopenia Pregnancy Contraindications

研究组 & 干预措施

M methylene blue and ozone

Active Comparator

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

干预措施: methylene blue (Drug)

M methylene blue and ozone

Active Comparator

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

干预措施: ozone (Drug)

P Placebo

Placebo Comparator

saline and oxygen mixed blood injection in early sepsis patients

干预措施: saline infusion (Other)

P Placebo

Placebo Comparator

saline and oxygen mixed blood injection in early sepsis patients

干预措施: oxygen (Other)

结局指标

主要结局

APACHE score

时间窗: 7 days

次要结局

  • ICU stay(30 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Emad Zarief , MD

Lecturer of Anesthesia and critical care Medicine

Assiut University

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Methylene Blue and Ozone in Early Sepsis | 临床试验