Table 3 Summary of primary and secondary outcomes for the ChloraLockTM pilot trial
Pilot trial outcomes | Analysis | Pass threshold |
|---|---|---|
 Primary outcomes | ||
  1. Consent rate: patients and SDMs approached who consent to randomization | Proportion | ≥ 80% |
  2. Recruitment rate: eligible patients who are randomized | Proportion | ≥ 80% |
  3. Protocol adherence: times ChloraLockTM is used in conjunction with usual locking procedures | Proportion | ≥ 90% |
  4. Comfort: staff comfort level with the device and trial protocol | Descriptive | NA |
 Secondary outcomes | ||
  1. Central line colonization: assessed for each arm as positive central line culture and negative peripheral poke | Proportion | NA |
  2. Bacteremia: assessed for each arm as positive stab cultures | Proportion | NA |
  3. Clinical end points: LOS in ICU, LOS in hospital, ICU mortality at 28 days, hospital mortality at 28 days | Median or mean proportions | NA |