JPRN-jRCT2032200381招募中2 期
Pilot Study of NOA-001 for ARDS (Acute Respiratory Distress Syndrome)
Miyakawa Jun0 个研究点目标入组 45 人开始时间: 2021年3月15日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 45
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 16age old 至 ot applicable（—）
- 性别
- All
入选标准
- •(Non-COVID-19 Cohort)
- •At Informed Consent
- •1)Patients with ARDS confirmed by the Berlin definition based on the following diagnostic criteria (1)-(4):
- •(1) Patients within 7 days from invasion or exacerbation of respiratory symptoms or acute onset of ARDS.
- •(2) Patients with respiratory failure not fully explained by cardiac failure or fluid overload; Need objective assessment (e. g., echo-cardiography) to exclude hydrostatic edema if no risk factor present
- •(3) Patients with bilateral opacities not fully explained by effusions, lobar/ lung collapse, or nodules on chest X-ray or CT scan
- •(4) Patients with PaO2/ FiO2 ratio <= 300 mmHg (PEEP >= 5 cmH2O)
- •2)Patients who are intubated and mechanically ventilated
- •3)Patients who can be enrolled in the study within 48 hours after ARDS diagnosis confirmed by Berlin definition
- •4)Patients aged >= 16 years at informed consent (Signed informed consent form from legally acceptable representative must be available if patient is aged < 20 years)
- •At Enrollment
- •1)Patients with PaO2/ FiO2 ratio >= 50 mmHg and <= 200 mmHg (PEEP >= 5 cmH2O)
- •2)Patients with bilateral opacities not fully explained by effusions, lobar/ lung collapse, or nodules on CT scan within 48 hours before enrollment
- •3)Patients who are intubated and mechanically ventilated
- •4)Patients who can be enrolled in the study within 48 hours after ARDS diagnosis confirmed by Berlin definition
排除标准
- •(Non-COVID-19 Cohort)
- •At Informed Consent
- •1)Patients with mechanical ventilation for more than 48 hours prior to ARDS diagnosis confirmed by Berlin definition
- •2)Patients who are considered to be extremely unlikely to withdraw from mechanical ventilation
- •3)Patients who are treated with ECMO or HFOV
- •4)Patients with renal dialysis therapy for chronic renal failure
- •5)Patients with congestive heart failure (NYHA class IV)
- •6)Patients with acuter left ventricular failure
- •7)Patients with liver failure (Child-Pugh grade C)
- •8)Patients who have burns in excess of 15% total body surface area
- •9)Patients after resuscitation from cardiac arrest
- •10)Patients with a history of hypersensitivity to the anticoagulants (Heparin or Nafamostat mesylate)
- •11)Patients who have received cytapheresis, blood purification therapy with cytokine adsorbing devices or endotoxin removal therapy within 7 days prior to informed consent
- •12)Patients with pregnancy or lactating
- •13)Patients tested positive for COVID-19
- •At Enrollment
- •1)Patients who are considered to be extremely unlikely to withdraw from mechanical ventilation
- •2)Patients who are treated with ECMO or HFOV after obtaining informed consent prior to enrollment
- •3)Patients with platelet count <= 50,000 /mm3 by the latest blood test
- •4)Patients who have received cytapheresis, blood purification therapy with cytokine adsorbing devices or endotoxin removal therapy between informed consent and enrollment
- •5)Patients whose life expectancy is <= 24 hours after enrollment
- •6)Patients after resuscitation from cardiac arrest between informed consent and enrollment
- •7)Patients tested positive for COVID-19 between informed consent and enrollment
研究者
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