Study protocol publication in BMJ Open Journal
On 21st June 2017 the study protocol was published online by Antje Neubert, Manuel Alberto Baarslag, Monique van Dijk, Joost van Rosmalen, Joseph F Standing, Yucheng Sheng, Wolfgang Rascher, Deborah Roberts, Jackie Winslade, Louise Rawcliffe, Sara M Hanning, Tuuli Metsvaht, Viviana Giannuzzi, Peter Larsson, Pavla Pokorná, Alessandra Simonetti and Dick Tibboel on behalf of the CloSed Consortium in the BMJ Open Journal.
The paper entitled “The CLOSED trial; CLOnidine compared with midazolam for SEDation of paediatric patients in the intensive care unit: study protocol for a multicentre randomised controlled trial” provides an overview of the study protocol: the trial aims, the methods used and the analysis foreseen, as well as the ethical considerations of such a paediatric multi-national trial.
This publication highlights CloSed trial aims: to provide data on the pharmacokinetics, safety and efficacy of clonidine for the sedation of mechanically ventilated patients with view to obtaining a European Paediatric-Use Marketing Authorisation (PUMA) and to perform pharmacogenomic assessments.
Discussion points include the study design, the study limitations, the role of researcher-driven studies, the risk to patients, the challenge to perform a trial compliant with Good Clinical Practice (GCP) and other rules and the trial status.
The full-text of this article is available at http://bmjopen.bmj.com/content/7/6/e016031.long#.