Clinical trial NCT02455492: Factors Associated With Perioperative Outcomes in Non-emergency Surgery
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Acute Coronary Syndrome
Pneumonia
Keywords: Mortality
Perioperative period
Elective surgical procedures
Lead sponsor: University of Nottingham
Sponsor class: OTHER
Collaborators: name: University of Wisconsin, Madison
First posted: 2015-05-27
Enrollment: 266436
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* None

Primary outcomes:
measure: Perioperative mortality (yes/no)
timeFrame: up to 60 days of surgery
Secondary outcomes:
measure: Acute coronary syndrome (yes/no)
timeFrame: within 30 days of surgery
measure: Pneumonia (yes/no)
timeFrame: within 30 days of surgery
Other outcomes:
Locations:
Study officials:
affiliation: University of Nottingham
name: Puja R Myles, PhD
role: STUDY_DIRECTOR
References: