2019-02-17
Effect of a Resuscitation Strategy Targeting Peripheral Perfusion Status vs Serum Lactate Levels on 28-Day Mortality Among Patients With Septic Shock
Publication
Publication
The ANDROMEDA-SHOCK Randomized Clinical Trial
J A M A: The Journal of the American Medical Association , Volume 321 - Issue 7 p. 654- 664
IMPORTANCE Abnormal peripheral perfusion after septic shock resuscitation has been
associated with organ dysfunction and mortality. The potential role of the clinical
assessment of peripheral perfusion as a target during resuscitation in early septic shock
has not been established.
OBJECTIVE To determine if a peripheral perfusion–targeted resuscitation during early
septic shock in adults is more effective than a lactate level–targeted resuscitation for
reducing mortality.
DESIGN, SETTING, AND PARTICIPANTS Multicenter, randomized trial conducted at 28 intensive
care units in 5 countries. Four-hundred twenty-four patients with septic shock were included
between March 2017 and March 2018. The last date of follow-up was June 12, 2018.
INTERVENTIONS Patients were randomized to a step-by-step resuscitation protocol aimed
at 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.
MAIN OUTCOMES AND MEASURES The primary outcomewas 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 (range, 0 [best] to 24 [worst]); death
within 90 days; mechanical ventilation–, renal replacement therapy–, and vasopressor-free
days within 28 days; intensive care unit and hospital length of stay.
RESULTS Among 424 patients randomized (mean age, 63 years; 226 [53%] women),
416 (98%) completed the trial. By day 28, 74 patients (34.9%) in the peripheral perfusion
group and 92 patients (43.4%) in the lactate group had died (hazard ratio, 0.75 [95%CI,
0.55 to 1.02]; P = .06; risk difference, −8.5%[95%CI, −18.2%to 1.2%]). Peripheral
perfusion–targeted resuscitation was associated with less organ dysfunction at 72 hours
(mean SOFA score, 5.6 [SD, 4.3] vs 6.6 [SD, 4.7]; mean difference, −1.00 [95%CI, −1.97 to
−0.02]; P = .045). There were no significant differences in the other 6 secondary outcomes.
No protocol-related serious adverse reactions were confirmed.
CONCLUSIONS AND RELEVANCE Among patients with septic shock, a resuscitation strategy
targeting normalization of capillary refill time, compared with a strategy targeting serum
lactate levels, did not reduce all-cause 28-day mortality.
Additional Metadata | |
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doi.org/10.1001/jama.2019.0071, hdl.handle.net/1765/115549 | |
J A M A: The Journal of the American Medical Association | |
Organisation | Erasmus MC: University Medical Center Rotterdam |
Hernández, G., Ospina-Tascon, GA, Damiani, L.P., Estenssoro, E., Dubin, A., Hurtado, J, … Bakker, J. (2019). Effect of a Resuscitation Strategy Targeting Peripheral Perfusion Status vs Serum Lactate Levels on 28-Day Mortality Among Patients With Septic Shock. J A M A: The Journal of the American Medical Association, 321(7), 654–664. doi:10.1001/jama.2019.0071 |