| Trial registration number
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DRKS00021447 |
Full text link
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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http://www.drks.de/DRKS00021447
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First author
Last imported at : Jan. 30, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Lukas Johannes Lehner
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Contact
Last imported at : Jan. 30, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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lukas.lehner@charite.de
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Registration date
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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2020-04-27
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Recruitment status
Last imported at : May 27, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Not recruiting
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Study design
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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RCT
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Allocation
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Randomized
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Design
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Parallel
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Masking
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Open label
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Center
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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multi-center
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Study aim
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Treatment
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Inclusion criteria
Last imported at : Jan. 30, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
Males or females aged 18-80, Positive PCR test for SARS-CoV-2, Vasoplegic shock (Noradrenalin > 0.2 µg/min/kg (aiming MAD = 65mmHg), CRP > 100 mg/l, Indication for hemodialysis
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Exclusion criteria
Last imported at : Jan. 30, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Patients receiving Tocilizumab (anti-IL6-receptor antibody), Pregnancy
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Number of arms
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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2
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Funding
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Charité Campus Virchow-Klinikum
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Inclusion age min
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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18
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Inclusion age max
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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80
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Countries
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Germany
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Type of patients
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Critical disease at enrollment
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Severity scale
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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8: Critical disease at enrollment
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Total sample size
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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100
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primary outcome
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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time to resolution of vasoplegic shock (defined as no need for vasopressors for at least 8 hours in order to sustain a MAD = 65mmHg) in days
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Notes
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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| Declared number of arm (2.0)
differs from found arms (3.0)
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Phase
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Phase 2
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Arms
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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[{"arm_notes": "", "treatment_id": 371, "treatment_name": "Cytosorb-therapy", "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"}]
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