Study of the Influence of the Moon and Seasons On Outcomes Following Surgery To Repair Ascending Aortic Dissection (ACS-MOON-1)

September 9, 2014 updated by: 22EON

The Influence of Lunar Cycle On Hospital Outcomes Following Ascending Aortic Dissection Repair

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.

Study Overview

Status

Completed

Conditions

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 4.12, 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 9.9 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: i.e., 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 3.1.0. Environmental factors will be calculated using the lunar package available from the CRAN software repository.

Study Type

Observational

Enrollment (Actual)

2684

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, W1T 7HA
        • National Institute for Cardiovascular Outcomes Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All acute ascending aortic dissection repair procedures recorded in the United Kingdom's National Adult Cardiac Surgery Audit.

Description

Inclusion Criteria:

  • acute dissection specified in aortic pathology

Exclusion Criteria:

  • missing data in the demographic covariates (age, sex)
  • missing data in the medical history (hypertension, diabetes, renal failure)
  • missing surgical procedure date

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Group A: Single procedure
Group A consists of patients recorded as having only had an ascending aortic dissection repair procedure.
Group B: Multiple procedures
Group B consists of patients who had an ascending aortic dissection repair procedure together with any other surgical intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
All cause in-hospital mortality
Time Frame: During hospital stay, an expected average of 8 days
During hospital stay, an expected average of 8 days
Length of stay in hospital among survivors to discharge
Time Frame: During hospital stay, an expected average of 18 days
During hospital stay, an expected average of 18 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

22EON

Collaborators

National Institute for Cardiovascular Outcomes Research

Investigators

  • Principal Investigator: Emmanuel Lazaridis, PhD, LLB, University College, London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 1998

Primary Completion (ACTUAL)

December 1, 2013

Study Completion (ACTUAL)

March 1, 2014

Study Registration Dates

First Submitted

September 8, 2014

First Submitted That Met QC Criteria

September 9, 2014

First Posted (ESTIMATE)

September 11, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

September 11, 2014

Last Update Submitted That Met QC Criteria

September 9, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NICOR-14-ACS-24

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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