Troponin Elevation After Major Noncardiac Surgery 2

• Conditions: Disability; Perioperative/Postoperative Complications; Perioperative Myocardial Infarction

• Registration Number: NCT03408522
• Lead Sponsor: UMC Utrecht

Brief Summary

Major adverse cardiac events (MACE) are a leading cause of mortality in patients undergoing noncardiac surgery. Patients with perioperative myocardial injury (PMI), defined as either myocardial infarction and lower elevations in cardiac troponin, are also at substantially increased risk of additional cardiac and noncardiac complications. Accordingly, it is plausible to assume that PMI negatively affects quality of life in terms of disability. The aim of this study is to investigate and compare the independent prognostic effects of the different PMI phenotypes (myocardial infarction and non-infarct troponin elevations) and noncardiac complications on disability in patients undergoing elective noncardiac surgery.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-01-15
• Study First Submitted QC: 2018-01-22
• Study First Posted: 2018-01-24
• Study Start: 2018-01-29
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-14
• Last Update Posted: 2019-01-16
• Primary Completion: 2019-06-30
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• ≥ 60 years old;
• Major noncardiac surgery defined as all noncardiac surgical procedures requiring an expected hospital stay of at least 24 hours;
• Elective surgery, defined as surgery that that has been preceded by a preoperative consultation at the anesthesia preoperative screening outpatient clinic.

Exclusion Criteria

• Patients unable to fully comply to study needs (e.g. legally incapable patients or patients unable to communicate in Dutch or English).
• Patients with an American Society of Anesthesiologists (ASA) Physical status 5

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disability	6 months after surgery	Disability is expressed by the World Health Organization Disability Assessment Score 2.0 (WHODAS 2.0), which is based on difficulties experienced by the respondent in different functional domains including, cognition, mobility, self-care, getting along, life activities and participation during the previous 30 days. Disability is defined as a decrement in each functioning domain corresponding to score between 0% and 100%, in which no disability stands for a score of 0% and full disability represents a score of 100%, including death.

Secondary Outcome Measures

Name	Time	Method
Major adverse cardiovascular event (MACE)	6 months after surgery
Length of hospital stay	1 week after surgery	the number of days from the end of surgery until day of discharge
All-cause mortality	6 months after surgery
Disability free survival	6 months after surgery	Disability free survival is defined as being alive with a WHODAS 2.0 score ≤ 25% and no increase of the pre-operative score ≥ 25% at 6 months after surgery.
Noncardiac major adverse postoperative events (MAPE)	1 week after surgery	Noncardiac MAPE is a composite outcome consisting of respiratory failure (including pneumonia and hypoxia or hypercapnia leading to ICU admission for respiratory support), sepsis, renal failure, unplanned ICU admission, unplanned medium care admission, reoperation

Trial Locations

Locations (3)

Toronto Western Hospital; 🇨🇦 Toronto, Ontario, Canada

Toronto General Hospital; 🇨🇦 Toronto, Ontario, Canada

UMC Utrecht; 🇳🇱 Utrecht, Netherlands