ANDROMEDA-SHOCK Trial

JAMA

February 17, 2019

Effect of a Resuscitation Strategy Targeting Peripheral Perfusion Status vs Serum Lactate Levels on 28-Day Mortality Among Patients With Septic Shock.

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.

ANDROMEDA-SHOCK Trial