Viewing Study NCT02236923



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Last Modification Date: 2024-10-26 @ 11:30 AM
Study NCT ID: NCT02236923
Status: COMPLETED
Last Update Posted: 2014-09-11
First Post: 2014-09-08

Brief Title: Study of the Influence of the Moon and Seasons On Outcomes Following Surgery To Repair Ascending Aortic Dissection
Sponsor: 22EON
Organization: 22EON

Study Overview

Official Title: The Influence of Lunar Cycle On Hospital Outcomes Following Ascending Aortic Dissection Repair
Status: COMPLETED
Status Verified Date: 2014-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: ACS-MOON-1
Brief Summary: That the full-moon stage of the lunar cycle is associated with reduced mortality and shorter length of stay in patients undergoing repair of aortic dissection after adjusting for seasonal effects demographics and cardiovascular risk factors
Detailed Description: The primary objective of this study is to determine whether the findings of Shuhaiber et al 2013 see citations may be confirmed using national audit data from the United Kingdom

A cohort of all acute ascending aortic dissection repair surgeries will be extracted from the National Adult Cardiac Surgery Audit NACSA database The current dataset version 412 available for download from the website of the National Institute for Cardiovascular Outcomes Research see links contains 168 fields that detail pre-operative patient characteristics operative details and post-operative outcomes The dataset is revised intermittently to meet the requirements of users and to respond to changes in the management of adult cardiac surgery however the fields to be analysed in this study have not been subject to any documented revisions The extracted data are to be cleaned using version 99 of the NACSA cleaning algorithm

Seasons are to be coded in the same way as in the published study autumn September 21 through December 20 winter December 21 through March 21 spring March 22 through June 21 and summer June 22 through September 20

Three definitions are to be used for the phases of the moon The first definition mirrors that employed in the motivating work each lunar cycle from new moon to new moon is to be split into four parts and labelled New Waxing Full and Waning The second definition centers each of those four labels around the named event ie the New period is to be centered around the new moon event itself instead of starting on the day of a new moon as in the first definition The third definition will split the lunar cycle into 8 event-centred periods called New Waxing crescent First quarter Waxing gibbous Full Waning gibbous Last quarter and Waning crescent

There is no need to explore the individual univariate relationships of predictors to outcomes in this work given its limited purpose to confirm the earlier multivariate findings The relationship between the environmental factors seasons and the lunar cycle and in-hospital mortality will be examined using multivariate logistic regression controlling for demographic and mortality risk factors The specific variables that can be included in common with the earlier work are age sex hypertension diabetes renal failure and an indicator of weekend admission The national audit does not include information on dyslipidaemia but it is felt that its exclusion from our model will not effect the comparability of our work to the earlier study because none of the earlier published models showed any effect of dyslipidaemia on surgical outcomes The relationship of the environmental factors to Length of stay LOS in survivors will be examined using a multivariate linear regression that includes the same risk factors as in the mortality model As in the published study LOS will be transformed to the natural logarithmic scale prior to analysis

We will run all analyses with and without a European system for cardiac operative risk evaluation score EuroSCORE II risk adjustment The EuroSCORE II was developed specifically to adjust for risk of in-hospital mortality It will be employed here despite its absence from the published models to ensure that risk adjustment prior to estimation of the contributions of the environmental factors will be as thorough as reasonably possible

All analyses will be performed using R version 310 Environmental factors will be calculated using the lunar package available from the CRAN software repository

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None