Statistical analysis plan for the BLING III study: a phase 3 multicentre randomised controlled trial of continuous versus intermittent ß-lactam antibiotic infusion in critically ill patients with sepsis.
Crit Care Resusc
; 23(3): 273-284, 2021 Sep 06.
Article
em En
| MEDLINE
| ID: mdl-38046078
ABSTRACT
Background:
The ß-Lactam Infusion Group (BLING) III study is a prospective, multicentre, open, phase 3 randomised controlled trial comparing continuous infusion with intermittent infusion of ß-lactam antibiotics in 7000 critically ill patients with sepsis.Objective:
To describe a statistical analysis plan for the BLING III study.Methods:
The statistical analysis plan was designed by the trial statistician and chief investigators and approved by the BLING III management committee before the completion of data collection. Statistical analyses for primary, secondary and tertiary outcomes and planned subgroup analyses are described in detail. Interim analysis by the Data Safety and Monitoring Committee (DSMC) has been conducted in accordance with a pre-specified DSMC charter. Results andconclusions:
The statistical analysis plan for the BLING III study is published before completion of data collection and unblinding to minimise analysis bias and facilitate public access and transparent analysis and reporting of study findings. Trial registrationClinicalTrials.gov Registry NCT03212990.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Idioma:
En
Revista:
Crit Care Resusc
Ano de publicação:
2021
Tipo de documento:
Article