Therapeutic landscape of sepsis management in the ICU: a descriptive analysis of clinical trials registered on ClinicalTrials.gov

Abstract

Objective: This study aimed to describe the characteristics, trends, and reporting of results for sepsis management trials registered on ClinicalTrials.gov. Methods: An extensive search was performed by ClinicalTrials.gov using 20 parallel strategies that combined condition-specific and intervention-specific terms. Eligible studies were interventional trials on adult sepsis, severe sepsis, or septic shock in intensive care unit (ICU). Data extracted included trial design, phase, sponsor class, geographic location, enrollment, interventions, and results posting. Temporal, geographic, and sponsor-related trends were examined. Results: A total of 1,916 interventional trials were included; 78% were randomized, and the median enrolment was 98 participants. Registrations increased significantly over time, and most of the trials were performed in Europe (33.1%) and North America (27.2%). Industry sponsors constituted 13.6% of trials and academic/other sponsors 82.2%. Pharmacological interventions (62.4%) dominated the landscape, followed by supportive/behavioral (17.6%) and device-based therapies (12.7%). Overall, results were posted for 12.5% of trials, with higher reporting for industry-sponsored, Phase 3/4, and North American trials. In multivariable analysis, industry sponsorship (adjusted OR 4.05, 95% CI 1.96-8.37) and trial phase (adjusted OR 1.92, 95% CI 1.02-3.60) remained significant independent predictors of results posting. Conclusion: The sepsis clinical trials landscape in ICUs is growing, mainly fueled by academic institutions and pharmacological interventions. Reporting trial results remained poor, underscoring the need for greater transparency and discussion of trial results to guide evidence-based care.