Effectiveness of treatment based on PiCCO parameters in critically ill patients with septic shock and/or acute respiratory distress syndrome: a randomized controlled trial.

PURPOSE

To compare treatment based on either PiCCO-derived physiological values or central venous pressure (CVP) monitoring, we performed a prospective randomized controlled trial with group sequential analysis.

METHODS

Consecutive critically ill patients with septic shock and/or ARDS were included. The planned total sample size was 715. The primary outcome was 28-day mortality after randomization. Participants underwent stratified randomization according to the classification of ARDS and/or septic shock. Caregivers were not blinded to the intervention, but participants and outcome assessors were blinded to group assignment.

RESULTS

The study was stopped early because of futility after enrollment of 350 patients including 168 in the PiCCO group and 182 in the control group. There was no loss to follow-up and data from all enrolled participants were analyzed. The result showed that treatment based on PiCCO-derived physiological values was not able to reduce the 28-day mortality risk (odds ratio 1.00, 95 % CI 0.66-1.52; p = 0.993). There was no difference between the two groups in secondary outcomes such as 14-day mortality (40.5 vs. 41.2 %; p = 0.889), ICU length of stay (median 9 vs. 7.5 days; p = 0.598), days free of vasopressors (median 14.5 vs. 19 days; p = 0.676), and days free of mechanical ventilation (median 3 vs. 6 days; p = 0.168). No severe adverse event was reported in both groups.

CONCLUSION

On the basis of our study, PICCO-based fluid management does not improve outcome when compared to CVP-based fluid management.