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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.
Originalsprog | Engelsk |
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Tidsskrift | Acta Anaesthesiologica Scandinavica |
Vol/bind | 66 |
Udgave nummer | 1 |
Sider (fra-til) | 156-162 |
Antal sider | 7 |
ISSN | 0001-5172 |
DOI | |
Status | Udgivet - jan. 2022 |
Bibliografisk note
Publisher Copyright:© 2021 Acta Anaesthesiologica Scandinavica Foundation.
Fingeraftryk
Dyk ned i forskningsemnerne om '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'. Sammen danner de et unikt fingeraftryk.Projekter
- 1 Afsluttet
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Handling Oxygen Targets in the Intensive Care Unit Trial
01/05/2019 → 30/04/2022
Projekter: Projekt › Forskning