Effect Of A Resuscitation Strategy Targeting Peripheral Perfusion Status Vs Serum Lactate Levels On 28-Day Mortality Among Patients With Septic Shock The ANDROMEDA-SHOCK Randomized Clinical Trial
Hernández G. et al, JAMA. 2019 Feb 19;321(7):654-664
SUMMARY:
The ANDROMEDA-SHOCK randomized clinical trial was conducted at 28 hospitals in 5 countries (Argentina, Chile, Colombia, Ecuador, Uruguay) on adult patients with early (< 4hours) septic shock admitted to the ICU
Randomized 424 patients to either peripheral perfusion targeted resuscitation (capillary refill) or lactate level targeted resuscitation (goal to clear lactate or drop level by 20%)
The primary outcome of mortality at 28 days was 43.4% in the lactate group and 34.9% in the peripheral perfusion group (P=0.06)
There was significantly less organ dysfunction at 72 hours after randomization in the peripheral perfusion group (mean difference in SOFA score, −1.00 P=0.045) but no significant between-group differences in the other 6 secondary outcomes including ventilator free days, pressor free days, hospital LOS and ICU LOS
Patients in the peripheral perfusion group received less resuscitation fluids within the first 8 hours (mean difference, −408 mL; P=0.01)
Unfortunately, this study is underpowered to answer the mortality question as their power calculation was based on an assumption that 28 day mortality would be reduced from 45% in the lactate group to 30% in the CR group – 15% is an unrealistic difference to achieve with a simple intervention
EDITOR’S COMMENTARY: This is a well-conducted RCT with some big differences between groups (mortality, fluid administered) that should make us think about our current practice of targeting resuscitation to lactate values in patients with septic shock. It is possible that the differences are due to more frequent assessment in the capillary refill group (every 30 minutes vs. every 2 hours), but it is nice to see a study touting the value of clinical exam over laboratory testing.
Copyright 2019 by Emergency Medical Abstracts – All Rights Reserved 07/19 - #1
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