Result reporting and early discontinuation of sepsis trials registered on ClinicalTrials.gov

Abstract

Objective

Sepsis is a leading cause of death from infectious disease or traumatic injury. The prevalence and predictor of results underreporting and early stop of sepsis clinical trials remain poorly studied. To fill the gap, we designed this study to characterize sepsis clinical trials registered on ClinicalTrials.gov, particularly to recognize features related to premature discontinuation and lack of results reporting.

Methods

We searched ClinicalTrials.gov to include interventional sepsis trials up to July 8, 2022. All structured data of the identified trials were extracted and reviewed. A descriptive analysis was conducted. Cox and logistic regression analyses were conducted to determine the significance of the association of trial characteristics with early termination and lack of results reporting.

Results

A total of 1654 records were identified, among which 1061 eligible trials were reserved. Results underreporting happened in 91.6% of these sepsis interventional trials. 12.0% were discontinued. Moreover, factors that led to the higher risk of discontinuation were the US-registered clinical research and the small sample size. The factor that contributed to results underreporting was non-US-registered clinical trials.

Conclusion

The frequent discontinuation and underreporting of sepsis trials have highly impaired the progress of sepsis management and studies. Therefore, solutions to early discontinuation and improving the quality of results dissemination remain an urgent problem.