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.

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 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 (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. Trial Registration: ClinicalTrials.gov Identifier: NCT03078712.

The effects of recruitment maneuver during noninvasive ventilation after coronary bypass grafting: A randomized trial.

OBJECTIVE: Pulmonary impairment is a common complication after coronary artery bypass graft procedure and may be prevented or treated by noninvasive ventilation. Recruitment maneuvers include sustained airway pressure with high levels of positive end-expiratory pressure in patients with hypoxemia, favoring homogeneous pulmonary ventilation and oxygenation. This study aimed to evaluate whether noninvasive ventilation with recruitment maneuver could safely improve oxygenation in patients with atelectasis and hypoxemia who underwent a coronary artery bypass grafting procedure. METHODS: Thirty-four patients admitted to our intensive care unit undergoing mechanical ventilation after surgery, with ratio of arterial oxygen partial pressure to fraction of inspired oxygen < 300 and radiologic atelectasis score ≥2, were included. The control group consisted of 16 randomized patients and the recruitment group consisted of 18 patients. After extubation, noninvasive ventilation was applied for 30 minutes 3 times a day with positive end-expiratory pressure of 8 cm H2O. The recruitment group received recruitment maneuver with positive end-expiratory pressure of 15 cm H2O and 20 cm H2O for 2 minutes each during noninvasive ventilation. We analyzed the arterial oxygen partial pressure in room air, radiologic atelectasis score, hemodynamic stability, and adverse events from extubation until discharge. RESULTS: Arterial oxygen partial pressure increased 12.6% ± 6.8% in the control group and 23.3% ± 8.5% in the recruitment group (P < .001). The radiologic atelectasis score was completely improved for 94.4% of the recruitment group with no adverse events, whereas 87.5% of the control group presented some atelectasis (P < .001). CONCLUSIONS: Noninvasive ventilation with recruitment maneuvers is safe, improves oxygenation, and reduces atelectasis in patients undergoing coronary artery bypass.