ANDROMEDA-SHOCK Trial

What was the research question?

• Is peripheral perfusion–targeted resuscitation more effective than a lactate level–targeted resuscitation during early septic shock in adults for reducing mortality.

How did they do it?

• Multicenter, randomized trial conducted at 28 intensive care units in 5 countries.

• Four-hundred twenty-four patients with septic shock were randomized to protocol that aims to either normalizing capillary refill time (n = 212) or normalizing or decreasing lactate levels at rates greater than 20% per 2 hours (n = 212), during an 8-hour intervention period.

• The primary outcome was all-cause mortality at 28 days.

• Secondary outcomes were organ dysfunction at 72 hours after randomization, as assessed by Sequential Organ Failure Assessment (SOFA) score, death within 90 days; mechanical ventilation-, renal replacement therapy-, and vasopressor-free days within 28 days; intensive care unit and hospital length of stay.

What did they find?

• Among 424 patients randomized (mean age, 63 years; 226 [53%] women), 416 (98%) completed the trial.

• 28-day mortality was 34.9% in the peripheral perfusion group compared to 43.4% in the lactate group had died (P = .06).

• Organ dysfunction at 72 hours was lower in the peripheral perfusion–targeted resuscitation compared to the lactate group (mean SOFA score 5.6 vs 6.6; P = .045).

• There were no significant differences in the other secondary outcomes, and no protocol-related serious adverse reactions were confirmed.

What are the limitations of the study?

• Nonblinded study but low potential for bias.

• No previous data were available to facilitate a power calculation.

• Interrater variability for capillary refill time was not evaluated.

What does it mean?

• 28-day mortality was not lower with a resuscitation strategy targeting normalization of capillary refill time compared with a strategy targeting serum lactate levels in patients with septic shock.