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

J

Jennifer Breel

Status

Enrolling

Conditions

Surgery, Cardiac
Female
Male

Treatments

Procedure: Cardiac surgery

Study type

Observational

Funder types

Other

Identifiers

NCT06554925
W22_050 # 22.081

Details and patient eligibility

About

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).

Full 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.

Enrollment

10,000 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

10,000 participants in 2 patient groups

Female
Description:
Female sex undergoing cardiac surgery
Treatment:
Procedure: Cardiac surgery
Male
Description:
Male sex undergoing cardiac surgery
Treatment:
Procedure: Cardiac surgery

Trial contacts and locations

1

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Central trial contact

Susanne Eberl, PhD; Jennifer S Breel, MSc

Data sourced from clinicaltrials.gov

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