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

Elderly Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03605134
• Other study ID #: Troponin
• Status: Recruiting
• Start date: August 23, 2018
• Est. completion date: May 28, 2020

Study information

• Verified date: April 2019
• Source: Universitair Ziekenhuis Brussel
• Contact: Veerle Van Mossevelde, Datanurse
• Phone: +32 2 476 31 34
• Email: veerle.vanmossevelde[@]uzbrussel.be
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 28, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Elderly
• Mortality
• Surgery--Complications

Intervention

Diagnostic Test:
• level of cardiac troponin
blood test
• diastolic function assessment
transthoracic echocardiography

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis Brussel	Jette	Vlaams Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	surgical mortality	30 days mortality	30 days
Secondary	diastolic function	transthoracic echocardiography	3 days