The Impact of Routine Measurement of Cardiac Troponin (hsTnT) on Outcome in Elderly Patients Undergoing Major Surgery

• Conditions: Elderly; Surgery--Complications; Mortality
• Interventions: Diagnostic Test: level of cardiac troponin; Diagnostic Test: diastolic function assessment

• Registration Number: NCT03605134
• Lead Sponsor: Universitair Ziekenhuis Brussel

Brief Summary

To document levels of cardiac troponin hsTnT in patients above 75y undergoing high risk surgery and the relationship between elevated levels and outcome in terms of hospital stay and 30 day mortality.

Detailed Description

Elevated troponin (Tn) hsTnT levels occur as a result of myocardial damage and are used in the diagnosis of myocardial infarction (MI). However, there are multiple different causes that also result in abnormal Tn levels, such as direct myocardial-cell injury, impaired renal excretion and sepsis. Because of this, elevated Tn level is a common finding in hospitalized patients.

Several studies on patients admitted to the intensive care unit (ICU) without MI show that Tn elevation is a mortality risk factor and an independent predictor of hospital mortality.

Up till now it is not yet known if the routine measurement of Tn in elderly patients undergoing surgery can significantly improve their outcome and that is the primary aim of this study. In addition, it is not known what the impact could be if a diastolic function assessment could be performed peri-operatively.

This study will examine the correlation between elevated Tn levels in elderly patients undergoing major surgery and their short-term outcome (in-hospital). Before and immediately after surgery, diastolic function will be assessed by means of transthoracic echocardiography (TTE).

Study Timeline

• Study First Submitted: 2018-06-28
• Study First Submitted QC: 2018-07-20
• Study First Posted: 2018-07-30
• Study Start: 2018-08-23
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-16
• Last Update Posted: 2019-04-17
• Primary Completion: 2019-12-31
• Study Completion: 2020-05-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• All patients ≥75 y undergoing elective and major surgery till we have collected an entire dataset of 100 patients.
• Only those patients will be included who are planned for elective and major surgery.

Exclusion Criteria

• Patients under the age of 75
• Intraoperative mortality
• Eye surgery
• Cardiac or thoracic surgery
• Patients undergoing surgery which is not withheld as major surgery
• For patients undergoing multiple surgeries for the same indication and during the same hospitalization, only the first surgery will be included

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
study group	level of cardiac troponin	level of cardiac troponin and diastolic function assessment by means of transthoracic echocardiography
study group	diastolic function assessment	level of cardiac troponin and diastolic function assessment by means of transthoracic echocardiography

Primary Outcome Measures

Name	Time	Method
surgical mortality	30 days	30 days mortality

Secondary Outcome Measures

Name	Time	Method
diastolic function	3 days	transthoracic echocardiography

Trial Locations

Locations (1)

Universitair Ziekenhuis Brussel; 🇧🇪 Jette, Vlaams Brabant, Belgium