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

Recruiting

• Conditions: Male; Surgery, Cardiac; Female
• Interventions: Procedure: Cardiac surgery

• Registration Number: NCT06554925
• Lead Sponsor: Jennifer Breel

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.

Study Timeline

• Study Start: 2022-03-01
• Study First Submitted: 2022-03-20
• Status Verified: 2024-08
• Study First Submitted QC: 2024-08-12
• Last Update Submitted: 2024-08-12
• Study First Posted: 2024-08-15
• Last Update Posted: 2024-08-15
• Primary Completion: 2030-03-01
• Study Completion: 2031-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Female	Cardiac surgery	Female sex undergoing cardiac surgery
Male	Cardiac surgery	Male sex undergoing cardiac surgery

Primary Outcome Measures

Name	Time	Method
Postoperative mortality	Measured at 5 years postoperatively	Incidence of perioperative mortality

Secondary Outcome Measures

Name	Time	Method
Postoperative complications (Morbidity)	Measured at 365 days	Incidence of peroperative and post-operative complications
Development of a predictive risk score using a composite outcome	Up to 30 days postoperatively	Predictive risk score

Trial Locations

Locations (1)

Academic Medical Center; 🇳🇱 Amsterdam, North Holland, Netherlands