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Clinical Trials/NCT06554925
NCT06554925
Recruiting
Not Applicable

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

Jennifer Breel1 site in 1 country10,000 target enrollmentMarch 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Female
Sponsor
Jennifer Breel
Enrollment
10000
Locations
1
Primary Endpoint
Postoperative mortality
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2022
End Date
March 1, 2031
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Jennifer Breel
Responsible Party
Sponsor Investigator
Principal Investigator

Jennifer Breel

Research coordinator

Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)

Eligibility Criteria

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

  • Not provided

Outcomes

Primary Outcomes

Postoperative mortality

Time Frame: Measured at 5 years postoperatively

Incidence of perioperative mortality

Secondary Outcomes

  • Postoperative complications (Morbidity)(Measured at 365 days)
  • Development of a predictive risk score using a composite outcome(Up to 30 days postoperatively)

Study Sites (1)

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