Journal article
Statistical analysis plan for the Prophylactic Melatonin for Delirium in Intensive Care (ProMEDIC): a randomised controlled trial
Trials, Vol.22(1), Art. 7
2021
Abstract
Rationale
Delirium is defined as acute organic brain dysfunction characterised by inattention and disturbance of cognition. It is common in the intensive care unit and is associated with poorer outcomes. Good quality sleep is important in the prevention and management of delirium. Melatonin is a natural hormone secreted by the pineal gland which helps in the regulation of the sleep-wake cycle. It is possible that melatonin supplementation in intensive care improves sleep and prevents delirium.
Methods and design
The ‘Prophylactic Melatonin for Delirium in Intensive Care’ study is a multi-centre, randomised, double-blinded, placebo-controlled trial. The primary objective of this study is to determine whether melatonin given prophylactically decreases delirium in critically ill patients. A total of 850 ICU patients have been randomised (1:1) to receive either melatonin or a placebo. Participants were monitored twice daily for symptoms of delirium.
Results
This paper and the attached additional files describe the statistical analysis plan (SAP) for the trial. The SAP has been developed and submitted for publication before the database has been locked and before the treatment allocation has been unblinded. The SAP contains details of analyses to be undertaken, which will be reported in the primary and secondary publications.
Discussion
The SAP details the analyses that will be done to avoid bias coming from knowledge of the results in advance. This trial will determine whether prophylactic melatonin administered to intensive care unit patients helps decrease the rate and the severity of delirium.
Trial registration
Australian and New Zealand Clinical Trial Registry (ANZCTR) ACTRN1261600043647, registration date: 06 April 2016. WHO Trial Number – U1111-1175-1814
Details
- Title
- Statistical analysis plan for the Prophylactic Melatonin for Delirium in Intensive Care (ProMEDIC): a randomised controlled trial
- Authors/Creators
- B. Wibrow (Author/Creator) - Sir Charles Gairdner HospitalF.E. Martinez (Author/Creator) - John Hunter HospitalA. Ford (Author/Creator) - Royal Perth HospitalE. Kelty (Author/Creator) - Centre for Applied Statistics, University of WA, Perth, AustraliaK. Murray (Author/Creator) - Centre for Applied Statistics, University of WA, Perth, AustraliaK.M. Ho (Author/Creator) - Murdoch UniversityE. Litton (Author/Creator) - St John of God Subiaco HospitalE. Myers (Author/Creator) - Sir Charles Gairdner HospitalM. Anstey (Author/Creator) - Sir Charles Gairdner Hospital
- Publication Details
- Trials, Vol.22(1), Art. 7
- Publisher
- BioMed Central
- Identifiers
- 991005541416607891
- Copyright
- © 2021 The Authors.
- Murdoch Affiliation
- Murdoch University
- Language
- English
- Resource Type
- Journal article
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- Collaboration types
- Domestic collaboration
- Citation topics
- 1 Clinical & Life Sciences
- 1.154 Assisted Ventilation
- 1.154.1403 Delirium
- Web Of Science research areas
- Medicine, Research & Experimental
- ESI research areas
- Clinical Medicine