(1428) Characteristics of Clinical Trials in Sepsis: Systematic Review of ClinicalTrials.gov in 25 Years

Introduction: Sepsis is one of the leading causes of human mortality. There is a paucity of clinical trials informing specific questions faced by sepsis. The ClinicalTrials.gov registry offers an opportunity to evaluate the clinical trials in sepsis. Here we analyze 25 years of sepsis clinical trial research.

Methods: We examined interventional trials registered with ClinicalTrials.gov from 1995–2020, focusing on study conditions and interventions to identify sepsis-related trials. Relevance to ID was manually confirmed for each programmatically identified trial. The clinical trials were classified according to the guidelines' (Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock: 2021.) treatment strategies.

Results: A total of 1316 clinical trials were selected in this study based on the sepsis ID and excluding adolescents or children under 18 years of age. Of the 1316 trials selected, 203 (15.4%) were Initial resuscitation and fluid therapy, 111(8.4%) were Screening for sepsis and performance improvement, 200 (15.2%) were Infection-Diagnosis, 195 (14.8%) were Infection-Antimicrobial Therapy, 104(7.9%) Renal Replacement Therapy and 110 (8.3%) were Nutrition. 393 (29.9%) were other septic studies (including Vasoactive Medications, Mechanical Ventilation, Immunotherapy et al). The number of sepsis trials increased gradually from 103 (Jan 1, 1995, through Dec 31, 2005) to 582 (Jan 1, 2016, through Oct 31, 2020), especially in terms of Initial resuscitation and fluid therapy, Antimicrobial therapy, Nutrition. The clinical trials in antimicrobial therapy were dominated by G+ bacteria, and antifungal-related clinical trials increasd year by year. Industry was the funding source in 13.8% of sepsis trials vs. 1.2% that were primarily NIH-funded.

Conclusions: This work is the first to characterize ID clinical trials registered in ClinicalTrials.gov in sepsis. At present, the treatment of sepsis still focuses on the use of Infection-antimicrobial, fluid resuscitation, diagnosis, and nutritional therapy. The limited number of and the scarcity of funding for septic clinical trials is concerning given the integral role of septic therapy in the clinical management of patients worldwide. A multidisciplinary collaboration to promote and fund more septic research is warranted.