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Factors Associated With Perioperative Outcomes in Non-emergency Surgery

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ClinicalTrials.gov Identifier: NCT02455492
Recruitment Status : Completed
First Posted : May 27, 2015
Last Update Posted : May 28, 2015
Sponsor:
Collaborator:
University of Wisconsin, Madison
Information provided by (Responsible Party):
University of Nottingham

Brief Summary:
This epidemiological study investigates the association of recent stroke, acute coronary syndrome or pneumonia and adverse perioperative outcomes following elective non-cardiac and cardiac surgery using routinely collected UK primary and secondary care patient data.

Condition or disease Intervention/treatment
Stroke Acute Coronary Syndrome Pneumonia Other: stroke or myocardial infarction or pneumonia

Detailed Description:

Previous studies have identified prior stroke, heart attack or current diabetes mellitus and anaemia as important risk factors for adverse outcomes following surgery. Recent heart attacks are associated with greater risks than older ones. While recent data suggests that newer strokes impart significantly greater risk than older strokes, there is a lack of concordance on the literature on this, despite the plausibility of the finding. Despite knowledge that prior pneumonia has long-term health risks, there is a lack of data on whether prior pneumonia influences perioperative risk or whether the time interval from pneumonia to surgery affects this relationship. Furthermore while diabetes mellitus and anaemia are known to be important perioperative risk factors, the relationship between haemoglobin concentration or HbA1c levels and perioperative outcomes is unclear. The aim of this epidemiological study is to explore these associations with perioperative risk in the United Kingdom Clinical Practice Research Datalink (with linkage to Hospital Episode Statistics data and Office of National Statistics mortality data).

The research aims are:

  1. To investigate the association between three recent acute medical events (stroke, pneumonia and MI) and adverse perioperative outcomes following non-cardiac and cardiac surgery.
  2. To investigate the association between time-elapsed between acute medical events (stroke, pneumonia and MI) and adverse perioperative outcomes following non-cardiac and cardiac surgery.
  3. To investigate numerical risk thresholds for haemoglobin and HbA1c that could predict adverse perioperative outcomes following non-cardiac and cardiac surgery.

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Study Type : Observational
Actual Enrollment : 266436 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: An Epidemiological Investigation Into the Association Between Recent Stroke, Acute Coronary Syndrome or Pneumonia and Adverse Perioperative Outcomes Following Elective Non-cardiac and Cardiac Surgery
Study Start Date : January 2004
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia


Intervention Details:
  • Other: stroke or myocardial infarction or pneumonia
    There are three main exposure groups with exposure defined as a binary variable (yes/no): Stroke in the six months prior to surgery; Myocardial infarction in the six months prior to surgery; Pneumonia in the six months prior to surgery


Primary Outcome Measures :
  1. Perioperative mortality (yes/no) [ Time Frame: up to 60 days of surgery ]
    all-cause mortality within the specified time frame; both in and out of hospital; as recorded in primary care patient record and validated using Office of National Statistics death certification records; unadjusted and adjusted relative risks will be calculated (odds ratios and hazard ratios)


Secondary Outcome Measures :
  1. Acute coronary syndrome (yes/no) [ Time Frame: within 30 days of surgery ]
    physician diagnosed and occurring within the specified time frame; as recorded in patient care record; unadjusted and adjusted relative risks will be calculated (odds ratios and hazard ratios)

  2. Pneumonia (yes/no) [ Time Frame: within 30 days of surgery ]
    physician diagnosed and occurring within the specified time frame; as recorded in patient care records; unadjusted and adjusted relative risks will be calculated (odds ratios and hazard ratios)



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
All patients within the Clinical Practice Research Datalink who have undergone a non-cardiac or cardiac elective procedure between 1/01/2004 and 31/12/2013.
Criteria

Inclusion Criteria:

  • Undergone a non-cardiac or cardiac elective procedure between 1/01/2004 and 31/12/2013

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02455492


Sponsors and Collaborators
University of Nottingham
University of Wisconsin, Madison
Investigators
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Study Director: Puja R Myles, PhD University of Nottingham

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Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT02455492     History of Changes
Other Study ID Numbers: 15_034R
First Posted: May 27, 2015    Key Record Dates
Last Update Posted: May 28, 2015
Last Verified: May 2015
Keywords provided by University of Nottingham:
Mortality
Perioperative period
Elective surgical procedures
Additional relevant MeSH terms:
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Pneumonia
Acute Coronary Syndrome
Syndrome
Disease
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Myocardial Ischemia
Heart Diseases