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A 1-Hour Resuscitation Bundle for Prehospital Management of Septic Shock
Romain Jouffroy1,2,3,4,5, Djillali Annane6,7,8,9, Caroline Elie10,11
1Intensive Care Unit, Service d'Aide Médicale Urgente (SAMU) de Paris, Necker - Enfants Malades Hospital, GHU Paris Centre, Assistance Publique - Hôpitaux de Paris, Paris Cité University, Paris, France.
Objectives:
To investigate the effect of a 1-hour resuscitation bundle, including early antibiotics, hemodynamic optimization with fluids and vasopressors as needed, and hydrocortisone therapy as needed, implemented in a prehospital setting by a mobile ICU (MICU) team, on 28-day mortality in adults with septic shock.
Design:
A multicenter, open-label, cluster-randomized study from May 09, 2016, to November 2, 2018.
Settings:
Prehospital emergency ambulance in France.
Patients:
Adults with suspected septic shock at the time of management by the prehospital MICU team.
Interventions:
The 1-hour resuscitation bundle included antibiotics, up to 35 mL/kg of ideal body weight of isotonic saline administered within the first 60 minutes, norepinephrine if mean blood pressure (MBP) remained less than 65 mm Hg or if diastolic blood pressure remained less than 40 mm Hg, and 100 mg of IV hydrocortisone when MBP remained less than 65 mm Hg while the patient was receiving greater than or equal to 1.5 mg/hr of norepinephrine.
Measurements And Main Results:
The primary outcome was 28-day all-cause mortality. Secondary outcomes included mortality rates in the ICU, at hospital discharge, and at 90 days, time alive free of vasopressor drugs, invasive mechanical ventilation, renal replacement therapy, and ICU and hospital lengths of stay. Of 398 participants, 17 did not consent; therefore, 381 participants (96%; mean age, 67 ± 15 yr) were analyzed. In total, 23 of 103 deaths (22%) occurred by 28 days in the 1-hour bundle arm and 76 of 278 deaths (27%) in the usual care arm (risk ratio, 0.81; 95% CI [0.61-1.08]; p = 0.16). The intracluster correlation coefficient was estimated at 0.005 ± 0.002. Secondary outcomes were similar between groups.
Conclusions:
The prehospital initiation of a 1-hour resuscitation bundle did not reduce 28-day all-cause mortality in adults with septic shock. Imbalances in patient enrollment between centers and a small difference in care provided between the groups may explain these results.
Trial Registration Number:
NCT02473263 (http://clinicaltrials.gov/).
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