Pilot Study of NOA-001
- Conditions
- ARDS (acute respiratory distress syndrome)
- Registration Number
- JPRN-jRCT2032200381
- Lead Sponsor
- Miyakawa Jun
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 45
(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
(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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Ventilator Free Days (VFD, Days alive and ventilator-free) (Day 28)
- Secondary Outcome Measures
Name Time Method Efficacy<br>1)All-cause Mortality [Time Frame: At Day 28, 60 and 90]<br>2)Mortality in ICU [Time Frame: Up to Day 28]<br>3)Mortality in Hospital [Time Frame: Up to Day 28]<br>4)Changes in PaO2/ FiO2 ratio<br>Safety<br>1)Adverse events<br>2)Device deficiency<br>3)Clinical examination values<br>4)Vital signs