Peyton Martin, BS
Research Assistant
The University of Texas MD Anderson Cancer Center, Texas, United States
Disclosure information not submitted.
Andres Laserna, MD
Resident Physician
Department of Anesthesiology and Perioperative Medicine, University of Rochester - Strong Memorial Hospital, United States
Disclosure information not submitted.
John Cuenca, MD (he/him/his)
Clinical Research Assistant
The University of Texas MD Anderson Cancer Center
Houston, Texas
Disclosure information not submitted.
Maria Lopez-Olivo, MD
Physician
The University of Texas MD Anderson Cancer Center, Texas, United States
Disclosure information not submitted.
Joseph Nates, MBA, MD
Professor, Deputy Chair, Director ICUs
University of Texas MD Anderson Center
Bellaire, Texas, United States
Disclosure information not submitted.
Title: Septic Shock Mortality Reported in Clinical Trials in the Last Decade: A Systematic Review
Introduction: Septic shock is considered a global emergency, with many randomized controlled trials (RCTs) performed attempting to reduce its mortality burden. These have reported their findings via a plurality of mortality endpoints. We aimed to identify septic shock mortality trends in the last decade via the most readily comparable endpoints.
Methods: We searched MEDLINE, EMBASE and Cochrane Library following the Cochrane methodology to identify RCTs performed on adult ICU patients with septic shock between 01/2008 and 08/2019. We included full articles and conference abstracts and extracted data including mortality rates and geographical region. Descriptive statistics were obtained using SPSS V26.
Results: 132 studies were included, of which 60 (45.5%) took place in Asia, 32 (24.2%) in Europe, and 12 (9.0%) in North America. 28-day mortality overall among intervention groups (15,140 patients) was 32.4% vs 32.9% in controls (14,923), p=0.418, with significantly lower mortality among intervention groups in 2010 (38.0% vs 41.5% in controls, 1,478/1,370 patients, p< 0.001), 2016 (25.0% vs 36.0%, 667/668, p=0.048), and 2019 (35.0% vs 50.0%, 302/302, p=0.033) studies. 28-day mortality was significantly higher in North American (NA) intervention and control groups compared to European (EU) studies (interventions: 41.5% vs 36.6% NA/EU, 587/5642 patients, p=0.023, and controls: 39.7% vs 34.0%, 532/5610, p=0.008) while not differing significantly from that reported in Asia (37.1% among intervention groups, 2051 patients, and 42.1% in controls, 1967 patients). Overall 90-day mortality did not differ between intervention (37.4%, 11,511 patients) and control groups (37.9%, 11,554), nor did overall hospital mortality (35.2% vs 36.3% interventions/controls, 6652/6648 patients), while overall ICU mortality was significantly lower in intervention groups (30.6%, 5,165 patients vs 32.8%, 5,064, p=0.019).
Conclusions: Overall 28-day mortality in septic shock RCTs of the last decade did not differ significantly between intervention and control groups, nor did 90-day or hospital mortality, while overall ICU mortality was significantly lower in the intervention groups of reporting studies. European septic shock RCT mortality was significantly lower than that reported in North America, both in intervention and control groups.