SEx-specific Differences in Cardiac Surgery Patients (SECS).
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorJennifer Breel
About this trial
The aim of this study is to evaluate the differences between females and males undergoing cardiac surgery. The investigators will look at perioperative factors such as adaption of body weight, previous medical history, pharmacokinetics, transfusion, coagulation, cardiopulmonary bypass (CPB) related factors, cardiac function, inotropic requirements, risk, and outcome scores as well as morbidity and mortality at sort-term (within 30 days) and long-term (90 days and 1 year).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients > 18 years
All patients who underwent cardiac surgery from 1 January 1998 in the AUMC, location VUmc, until 1 June 2021.
Disqualifiers
None
Trial population
The study population will consist of male and female patients, 18 years and older. The study group consists of all patients who underwent cardiothoracic surgery from 1998 in the AUMC, location VUmc until June 2021. Observational retrospective data collection from the mandatory Quality Assurance database of the Netherlands Heart Registry, supplemented with data from the electronic patient files (EPIC).
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Cardiac surgery
Procedure/SurgeryThe difference in males and females undergoing cardiac surgery of all types
Treatment groups
10,000 Participants
are divided into 2 treatment groupsGroup A: Female1 intervention
Group B: Male1 intervention
Trial outcomes
Primary outcomes
1
Postoperative mortality
Incidence of perioperative mortality
Time frame
Measured at 20 years postoperatively2
Postoperative mortality
Incidence of perioperative mortality
Time frame
Measured at 30 days postoperatively3
Postoperative mortality
Incidence of perioperative mortality
Time frame
Measured at 1 year postoperatively4
Postoperative mortality
Incidence of perioperative mortality
Time frame
Measured at 5 years postoperativelySecondary outcomes
1
Postoperative complications (Morbidity)
Incidence of peroperative and post-operative complications
Time frame
Measured at 30 days2
Postoperative complications (Morbidity)
Incidence of peroperative and post-operative complications
Time frame
Measured at 90 days3
Postoperative complications (Morbidity)
Incidence of peroperative and post-operative complications
Time frame
Measured at 365 days4
Development of a predictive risk score using a composite outcome
Predictive risk score
Time frame
Up to 30 days postoperativelySponsors and contacts
Click on the lead sponsor to view all of their trials.
Jennifer Breel
Lead sponsor
Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)
Sponsor institution
Source ClinicalTrials.gov