Effect of Left Ventricle Diastolic Dysfunction on Outcomes in Female Cardiac Surgery Patients

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

About this trial

The aim of this study is to evaluate the differences between males and females with LVDD, undergoing cardiac surgery. The investigators will look at perioperative factors such as body weight, body surface area, previous medical history, cardiac function measured by amongst others, transoesophageal echocardiography and haemodynamic parameters, transfusion, coagulation, cardiopulmonary bypass (CPB) related factors, inotropic requirements, risk, and outcome scores as well as complications, morbidity and mortality at 30 days. The investigators will evaluate these variables in an observational setting, with the goal of improving outcome in females after cardiac surgery in the future.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

All patients >18 years, who undergo cardiac surgery from 1 January 2023 till 31 December 2026 in the Amsterdam UMC

Disqualifiers

Patients who object to the re-use of their care data

Trial population

Adult patients undergoing cardiac surgery will be asked for permission to use data collected as standard-of-care

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Left ventricular diastolic dysfunction

number of patients with LVDD (grade I - III) before and after CPB. LVDD is measured by using the ratio of trans-mitral early flow velocity to early mitral annular tissue velocity (E/E')

Time frame
Before statrt bypass and end of bypass

Secondary outcomes

1

Composite endpoint

Composite endpoint: Mortality,Cerebrovascular accident (CVA), with persistent neurological disability, Acute kidney injury (AKI), as defined by KDIGO 2012,Low cardiac output syndrome (LCOS) with a vasoactive-inotropic score (VIS) \> 45 or need for cardiac assist device,Pulmonary (and other) complications requiring ventilation \>48 hours

Time frame
measured 30 days after surgery

Other outcomes

Sponsors and contacts

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