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SEx-specific Differences in Cardiac Surgery Patients (SECS).

SEx-specific Differences in Cardiac Surgery Patients (SECS). A Retrospective Registration and Evaluation of Characteristics and Perioperative Management of Cardiac Surgery Patients

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06554925
Acronym
SECS
Enrollment
10000
Registered
2024-08-15
Start date
2022-03-01
Completion date
2031-03-01
Last updated
2024-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Female, Male, Surgery, Cardiac

Keywords

anesthesia, sex-specific differences, cardiac surgery, care pathways

Brief summary

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).

Detailed description

There are now an increasing number of studies on preoperative cardiovascular differences in females and males, but no study to date has focused on a female-specific approach to perioperative anaesthesia and critical care in cardiac surgery patients. Given the higher mortality and morbidity in females after cardiac surgery, as well as the abovementioned sex differences, it is likely that females require different perioperative care than males, for better and faster recovery. The investigators hypothesise that females require different perioperative care (pathways) compared to males when undergoing cardiac surgery. The investigators would therefore like to investigate which factors are different in female and male patients, by setting up a database of perioperative parameters. By identifying the factors that adversely affect morbidity and mortality in females and linking these parameters, the investigators would like to improve outcome in fmales after cardiac surgery.

Interventions

PROCEDURECardiac surgery

The difference in males and females undergoing cardiac surgery of all types

Sponsors

Jennifer Breel
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients \> 18 years * All patients who underwent cardiac surgery from 1 January 1998 in the AUMC, location VUmc, until 1 June 2021.

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frameDescription
Postoperative mortalityMeasured at 20 years postoperativelyIncidence of perioperative mortality

Secondary

MeasureTime frameDescription
Postoperative complications (Morbidity)Measured at 30 daysIncidence of peroperative and post-operative complications
Development of a predictive risk score using a composite outcomeUp to 30 days postoperativelyPredictive risk score

Countries

Netherlands

Contacts

Primary ContactJennifer S Breel, MSc
j.s.breel@amsterdamumc.nl+31610019257
Backup ContactSusanne Eberl, PhD
s.eberl@amsterdamumc.nl+31610019257

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026