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NCT Number: NCT06554925

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

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).

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Key information

Conditions

Female Male Surgery, Cardiac

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cardiac surgery

Procedure

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

Primary outcomes

  1. Postoperative mortality

    Time frame: Measured at 20 years postoperatively

    Incidence of perioperative mortality

  2. Postoperative mortality

    Time frame: Measured at 30 days postoperatively

    Incidence of perioperative mortality

  3. Postoperative mortality

    Time frame: Measured at 1 year postoperatively

    Incidence of perioperative mortality

  4. Postoperative mortality

    Time frame: Measured at 5 years postoperatively

    Incidence of perioperative mortality

Secondary outcomes

  1. Postoperative complications (Morbidity)

    Time frame: Measured at 30 days

    Incidence of peroperative and post-operative complications

  2. Postoperative complications (Morbidity)

    Time frame: Measured at 90 days

    Incidence of peroperative and post-operative complications

  3. Postoperative complications (Morbidity)

    Time frame: Measured at 365 days

    Incidence of peroperative and post-operative complications

  4. Development of a predictive risk score using a composite outcome

    Time frame: Up to 30 days postoperatively

    Predictive risk score

Study contacts

Contact information is provided by the study sponsor or research team.

Jennifer S Breel, MSc

CONTACT

[email protected]

+31610019257

Susanne Eberl, PhD

CONTACT

[email protected]

+31610019257

Sponsors and collaborators

Lead sponsor

Jennifer Breel

Other

Registry information

Official study title

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

Acronym: SECS

Important dates

Study start
2022
Primary completion
2030
Study completion
2031
First posted
Aug 15, 2024
Registry last updated
Aug 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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