Is early goal-directed therapy associated with a higher risk of adverse events?

The Japanese Clinical Practice Guidelines for Management of Sepsis and Septic Shock 2016 suggested against the use of the early goal-directed therapy (EGDT) in patients with septic shock. This recommendation was based on the three large-scale trials (ProCESS, ARISE, and ProMISe). Although the three trials showed no difference in mortality between EGDT and usual care, the guidelines determined that the potential harms presented by EGDT likely outweigh its potential benefits. On the contrary, analysis of data from the three trials showed an approaching statistical significance lower risk of serious adverse events in the EGDT group compared to usual care (risk difference = − 1%, 95% confidence interval; − 2% to 0%, P = 0.05). EGDT may still be beneficial in patients with high disease severity and low central venous oxygen saturation, especially when managed by less experienced staff.