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Column | Value |
---|---|
Trial registration number | NCT04341285 |
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
|
First author
Last imported at : June 11, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
|
Contact
Last imported at : June 11, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
peter.rosenberger@med.uni-tuebingen.de |
Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
2020-04-10 |
Recruitment status
Last imported at : June 11, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Withdrawn |
Study design
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
RCT |
Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Randomized |
Design
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Parallel |
Masking
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Open label |
Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
single-center |
Study aim
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Treatment |
Inclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
inclusion criteria: - covid-19positive(+) ards as defined according to the berlin definition - ratio of partial pressure arterial oxygen and fraction of inspired oxygen (pao2/ fio2) ≤100 - bilateral opacities consistent with pulmonary edema on frontal chest radiograph - requirement for positive pressure ventilation via an endotracheal tube or non-invasive ventilation - no clinical evidence of left atrial hypertension, or if measured, a pulmonary arterial wedge pressure (paop) less than or equal to 18 mmhg. - ≤ 7 days from the initiation of mechanical ventilation at the time of randomization. - patients must be enrolled within 96 hours of onset of ards - |
Exclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
- covid-19negative(-) ards - age less than 18 years - more than 7 days since initiation of mechanical ventilation - more than 96 hours since meeting ards criteria - patient, surrogate or physician not committed to full intensive care support. - pregnancy |
Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
2 |
Funding
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
University Hospital Tuebingen |
Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
18 |
Inclusion age max
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
None |
Countries
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Germany |
Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Severe/critical disease at enrollment |
Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
7: Severe/critical disease at enrollment |
Total sample size
Last imported at : June 11, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
0 |
primary outcome
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
28 day all cause mortality |
Notes
Last imported at : Oct. 26, 2020, 11:31 p.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 : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "Early implantation", "treatment_id": 440, "treatment_name": "Ecmo", "treatment_type": "Life support", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "Late implantation", "treatment_id": 440, "treatment_name": "Ecmo", "treatment_type": "Life support", "pharmacological_treatment": "Non pharmacological treatment"}] |