Article
Hernández G, Ospina-Tascón GA, Damiani LP, et al. 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. JAMA. 2019;321(7):654-664.
OBJECTIVE
To determine whether capillary refill is as accurate in guiding resuscitation efforts in septic shock as measuring lactate levels
BACKGROUND
Hyperlactinemia is one marker of hypoperfusion among many that the Surviving Sepsis Campaign has proposed to guide hemodynamic resuscitation. Yet hyperlactinemia is not only present in shock states, and efforts to measure lactate may not be readily available in all health care settings. Moreover, lactate levels may not immediately decrease or resolve in septic shock patients. Capillary refill time is an alternative, readily available and resource independent means to assess tissue hypoperfusion that might be just as accurate in guiding interventions and resuscitation in septic shock.
POPULATION
Patients, aged ≥ 18 yrs with septic shock admitted to the ICU. Septic shock was defined as suspected or confirmed infection plus hyperlactinemia ≥ 2 and requiring vasopressors to maintain MAP > 65 after a fluid bolus of 20 cc/kg over min.
DESIGN
Multi-center (28 hospitals, 5 countries - Argentina, Chile, Columbia, Ecuador, Uruguay), randomized controlled trial of 424 patients with early septic shock.
Intervention
Patients were randomized to a standardized resuscitation protocol targeting capillary refill time (peripheral perfusion group) vs normalizing or decreasing lactate levels (lactate group) by 20% at 2-hour intervals over a 8-hour total intervention period.
Primary Outcome
All-cause mortality at 28 days.
Secondary Outcome(s)
- Organ dysfunction at 72 hours
- Death within 90 days
- Need for mechanical ventilation
- Need for renal replacement therapy
- Vasopressor-free days within 28 days
- Intensive care unit and hospital length of stay
Results
28-day mortality: 74 pts (34.9%) in peripheral perfusion group vs. 94 (42.4%) in the lactate group (hazard ratio, 0.75 [95% CI, 0.55 to 1.02]; P = .06; risk difference, −8.5% [95% CI, −18.2% to 1.2%]
Organ function: There was significantly less organ dysfunction at 72 hours after randomization in the peripheral perfusion group (mean difference in SOFA score, −1.00 [95% CI, −1.97 to −0.02]; P = .045)
Strengths
- Multicenter, randomized controlled trial
- Assessment of fluid responsiveness was pretty robust (assessment every 30 minutes at 500 cc increments)
- Follow-up for primary outcomes was excellent.
- Well-balanced study arms
- Relatively good protocol adherence between the groups
- Shows that using capillary refill is as least as good as measuring lactate in guiding resuscitation efforts in septic shock
Limitations
- 20 cc/kg bolus was provided in lieu of the typical CMS 30 cc/kg bolus.
- Non-blinded study (ie, potential for bias)
- The study may have been underpowered to detect a difference between the 2 treatment groups (power calculations were based on prior observational studies; there was no prior CRT with which to make an accurate power calculation).
- Interrater variability for measuring capillary refill time was not assessed.
- Randomization was not stratified by site.
- ICU-only study
- Only septic shock studied
- Resuscitation protocol was relatively complex.
Conclusions
Capillary refill is as least as good as measuring lactate in guiding resuscitation efforts in septic shock. Moreover, using a lactate-driven resuscitation strategy led to use of more pressors and more IV fluid administration without any change in all-cause mortality.