Table 3 Secondary outcomes for the STRIPES pilot study
Outcome | Metric for analysis |
|---|---|
Adherence to the protocol: | We will consider adherence adequate if each of goals a through c is met in 80 % of enrolled patients: |
a. Time to administration of the first dose of study drug b. Weaning of drug to q8h when hemodynamically stable c. Discontinuation of drug when off all vasoactive infusions | a. Goal is <8 h from starting vasoactive medication b. Goal is to wean within 12 h of no escalation of therapy c. Goal is to discontinue between 12 and 18 h after vasoactive infusion stopped |
Open-label steroid use | We will consider the number of patients started on open-label steroids to be acceptable if it occurs in <10 % of patients |
Clinical outcomes: | |
a. Adverse events b. Clinical endpoints | a. Severe bleeding, secondary infections, and use of insulin infusions b. Time to discontinuation of vasoactive infusion and incidence of mortality |
Successful blood sampling and processing | The percentage of patients from whom blood samples are sent |
The percentage of samples sent that are successfully received and analyzed in their respective labs |