NHLBI ARDS Network

I am attaching the latest draft of the main response to the PRC regarding the rationale for going ahead with the original proposal of co-enrollement in the ALTA vs placebo and the two nutrition protocols. This tries to justify the 2x2x2 design, the issue that was discussed this week on the SC on Monday, July 10 and we voted as a SC 8-3 to go forward on.

I am attaching this latest draft which includes modifications by Gordon and others including a recent input from David S with some statistical considerations.

Please review this as I would like to have your input before providing my (our) ALTA input.

Other issues to discuss today include

1. Near final decisions on the nebulizers we will administer
2. Issue of whether the pC02 limit should be broadened to 50 mmHg - I have thought about it and think it is on balance not a good ided but we should briefly discuss it.
3. The albuterol generic formulations we will be able to use - Taylor spoke to someone at the FDA about 8 different preparations that are allowed.
4. The issue of preservatives in the albuterol, such as sulfites.
5. The nature of the placebo and how to prepare it.
6. Which biomarkers would be best to mandate as oppose to leave for ancillary studies.
7. Again revisit the issue of plasma albuterol levels, pros and cons