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CompletedNCT02455492Updated May 28, 2015

Factors Associated With Perioperative Outcomes in Non-emergency Surgery

An observational study in Stroke, Acute Coronary Syndrome and Pneumonia, sponsored by University of Nottingham. Completed. Per ClinicalTrials.gov, last updated 2015-05-28.

Sponsored by University of Nottingham · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
266,436
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Stroke
  • Acute Coronary Syndrome
  • Pneumonia

Keywords

  • Mortality
  • Perioperative period
  • Elective surgical procedures
03

In context

Pneumonia

2,044 studies on the registry are indexed under Pneumonia; 283 are open to participants now.

This study's enrollment of 266,436 is above the median of 203 across 688 observational studies indexed under Pneumonia.

Browse Pneumonia studies →

Lead sponsor

University of Nottingham is the lead sponsor of 455 studies on the registry; 77 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
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.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • None
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
266,436 participants (actual)
Patient registry
No

Interventions

  • Otherstroke 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

06

What researchers measure

Primary outcomes

  1. Perioperative mortality (yes/no)

    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)

    Time frame: up to 60 days of surgery

Secondary outcomes

  1. Acute coronary syndrome (yes/no)

    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)

    Time frame: within 30 days of surgery

  2. Pneumonia (yes/no)

    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)

    Time frame: within 30 days of surgery

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 28, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02455492
Lead sponsor
University of Nottingham
Collaborators
University of Wisconsin, Madison
Responsible party
Sponsor
First posted
May 27, 2015
Start date
Jan 2004
Primary completion
Dec 2013
Completion
Dec 2013
Last update
May 28, 2015

Study contacts

Puja R Myles, PhD
study director · University of Nottingham

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2015. You cannot join it, but the record below documents what was studied.

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