Interactions in clinical trials: Protocol and statistical analysis plan for an explorative study of four randomized ICU trials on use of pantoprazole, oxygenation targets, haloperidol and intravenous fluids

Olav L. Schjørring*, Theis Lange, Mette Krag, Nina Christine Andersen-Ranberg, Tine S. Meyhoff, Søren Marker, Thomas L. Klitgaard, Stine Estrup, Morten Hylander Møller, Bodil S. Rasmussen, Lone M. Poulsen, Anders Perner

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Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

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Abstract

Background: Intensive care unit (ICU) patients receive numerous interventions, but knowledge about potential interactions between these interventions is limited. Co-enrolment in randomized clinical trials represents a unique opportunity to investigate any such interactions. We aim to assess interactions in four randomized clinical trials with overlap in inclusion periods and patient populations. Methods: This protocol and statistical analysis plan describes a secondary explorative analysis of interactions in four international ICU trials on pantoprazole, oxygenations targets, haloperidol and intravenous fluids, respectively. The primary outcome will be 90-day all-cause mortality. The secondary outcome will be days alive and out of hospital in 90 days after randomization. All patients included in the intention-to-treat populations of the four trials will be included. Four co-primary analyses will be conducted, one with each of the included trials as reference using a logistic regression model adjusted for the reference trial's stratification variables and for the co-interventions with interactions terms. The primary analytical measure of interest will be the analyses’ tests of interaction. A p-value below.05 will be considered statically significant. The stratification variable- and co-intervention-adjusted effect estimates will be reported with 95% confidence intervals without adjustments for multiplicity. Conclusion: This exploratory analysis will investigate the presence of any interactions between pantoprazole, oxygenation targets, haloperidol and amount of intravenous fluids in four international ICU trials using co-enrolment. Assessment of possible interactions represents valuable information to guide the design, statistical powering and conduct of future trials.

OriginalsprogEngelsk
TidsskriftActa Anaesthesiologica Scandinavica
Vol/bind66
Udgave nummer1
Sider (fra-til)156-162
Antal sider7
ISSN0001-5172
DOI
StatusUdgivet - jan. 2022

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© 2021 Acta Anaesthesiologica Scandinavica Foundation.

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