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Trial - NCT04708457


Column Value
Trial registration number NCT04708457
Full text link
Last imported at : Jan. 16, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04708457

First author
Last imported at : Jan. 16, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Anne Mather

Contact
Last imported at : Jan. 16, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

anne.mather@monash.edu

Registration date
Last imported at : Jan. 16, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

2021-01-14

Recruitment status
Last imported at : Jan. 16, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Not recruiting

Study design
Last imported at : Jan. 16, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Jan. 16, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Jan. 16, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Jan. 16, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Blind label

Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

multi-center

Study aim
Last imported at : Jan. 16, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

inclusion criteria: laboratory confirmed severe acute respiratory infection (sari) pneumonitis such as coronavirus disease of 2019 (covid-19) or influenza, and ≥5 days of mechanical ventilation, and moderate to severe respiratory failure as shown by either the ratio of partial pressure of oxygen and the fracture of inspired oxygen (pao2:fio2 rati)o <150 for >6 hours or the potential of hydrogen (ph) <7.30 with carbon dioxide (co2) >50mmhg for 6 hours, and are unable to pass a spontaneous breathing trial.

Exclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

age ≥70 year old extubation likely in next 24-48 hours duration of mechanical ventilation ≥7days ≥2 non-pulmonary organ failures (as scored by the sequential oxygen failure assessment (sofa) score) need for immediate vv ecmo (as per eolia (research study) criteria*) requirement for va ecmo clinical frailty or ≥2 major comorbidities the physician deems the study is not in the patient's interest eolia criteria (p:f <50 for 3 hours, p:f<80 for 6 hours, ph<7.25 with carbon dioxide partial pressure (pco2) >60 for >6 hours

Number of arms
Last imported at : Jan. 16, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : Jan. 16, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Australian and New Zealand Intensive Care Research Centre

Inclusion age min
Last imported at : Jan. 16, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Jan. 16, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

70

Countries
Last imported at : Jan. 16, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Australia;Germany

Type of patients
Last imported at : Jan. 16, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Critical disease at enrollment

Severity scale
Last imported at : Jan. 16, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

8: Critical disease at enrollment

Total sample size
Last imported at : Jan. 16, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

12

primary outcome
Last imported at : Jan. 20, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Number of participants who have SARI and have been mechanically ventilated for at least 5 days.

Notes
Last imported at : Jan. 16, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

Not reported

Arms
Last imported at : Jan. 16, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 440, "treatment_name": "Ecmo", "treatment_type": "Life support", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]