Factors Associated With Perioperative Outcomes in Non-emergency Surgery

May 27, 2015 updated by: University of Nottingham

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

266436

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • None

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
up to 60 days of surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
within 30 days of surgery
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)
within 30 days of surgery

Collaborators and Investigators

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

Sponsor

University of Nottingham

Collaborators

University of Wisconsin, Madison

Investigators

  • Study Director: Puja R Myles, PhD, University of Nottingham

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, 2004

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

May 22, 2015

First Submitted That Met QC Criteria

May 26, 2015

First Posted (Estimate)

May 27, 2015

Study Record Updates

Last Update Posted (Estimate)

May 28, 2015

Last Update Submitted That Met QC Criteria

May 27, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15_034R

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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