Clinical trial NCT03605134: The Impact of Routine Measurement of Cardiac Troponin (hsTnT) on Outcome in Elderly Patients Undergoing Major Surgery
Official title: The Impact of Routine Measurement of Cardiac Troponin (hsTnT) on Outcome in Elderly Patients Undergoing Major Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Surgery--Complications
Mortality
Elderly
Keywords: troponin
diastolic function
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2018-07-30
Enrollment: 100
Sex: ALL
Minimum age (years): 75
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All surgical patients above 75 years old

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).

Eligibility criteria: 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

Primary outcomes:
measure: surgical mortality
timeFrame: 30 days
Secondary outcomes:
measure: diastolic function
timeFrame: 3 days
Other outcomes:
Locations:
city: Jette
country: Belgium
facility: Universitair Ziekenhuis Brussel
state: Vlaams Brabant
Study officials:
affiliation: Universitair Ziekenhuis Brussel
name: jan Poelaert, PhD, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitair Ziekenhuis Brussel
name: Patrice Forget, PhD, MD
role: STUDY_CHAIR
References: