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
|Condition or disease||Intervention/treatment|
|Stroke Acute Coronary Syndrome Pneumonia||Other: stroke or myocardial infarction or pneumonia|
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:
- To investigate the association between three recent acute medical events (stroke, pneumonia and MI) and adverse perioperative outcomes following non-cardiac and cardiac surgery.
- 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.
- To investigate numerical risk thresholds for haemoglobin and HbA1c that could predict adverse perioperative outcomes following non-cardiac and cardiac surgery.
|Study Type :||Observational|
|Actual Enrollment :||266436 participants|
|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|
- 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
- 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)
- 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)
- 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)
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
|Study Director:||Puja R Myles, PhD||University of Nottingham|