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Posted On: 12/31/2020 4:53:42 AM
Post# of 148903
It's interesting the FDA are excluding from eIND "mechanically ventilated with PEEP <15 cmH20 with Pa02/FiO2 >150 mmHg and on vasopressors >48 hours."
Whereas in the CD12 protocol, inclusion criteria is "Subject, if intubated, positive endexpiratory pressure (PEEP) <15 cmH2O with PaO2/FiO2 >150 mmHg."
I don't know the medical reasons for departing from the trial protocol, but what this leads me to believe is that the FDA has seen some of the trial data for them to make such a specific recommendation. If blinded, I can't see any basis for this change.
Whereas in the CD12 protocol, inclusion criteria is "Subject, if intubated, positive endexpiratory pressure (PEEP) <15 cmH2O with PaO2/FiO2 >150 mmHg."
I don't know the medical reasons for departing from the trial protocol, but what this leads me to believe is that the FDA has seen some of the trial data for them to make such a specific recommendation. If blinded, I can't see any basis for this change.
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