Towards a Sex-specific Female Enhanced Recovery After Cardiac Surgery'' (F-ERAS) Pathway:

Study Overview
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Brief Summary
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The aim of this study is to evaluate the differences between men and women undergoing cardiac surgery. We will look at perioperative factors such as body weight, body surface area, 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 30 and 90 days, 1, 5, and 10 years.

Detailed Description
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Observational, multicentre, retrospective data collection from the mandatory Quality Assurance database (the Netherlands Heart Registry, (NHR), supplemented with data from the electronic patient files (EPIC). The retrospective data is already available. In addition, we will continue the retrospective study into a prospective registry of data after the analysis of the retrospective data. Patients will be approached one, five and ten years after the operation and a questionnaire will be sent to document quality of life. No research-related interventions other than questionnaires will be performed

Official Title
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Towards a Sex-specific Female Enhanced Recovery After Cardiac Surgery'' (F-ERAS) Pathway: An Observational Registration and Evaluation of Characteristics and Perioperative Management of Cardiac Surgery Patients

Conditions
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Female, Male, Surgery,Cardiac

Intervention / Treatment
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* Procedure: Cardiac surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients > 18 years All patients who underwent cardiac surgery from 1 January 2016 to the start of the study, in either of the centres (AMC or VUmc) (retrospective) All patients undergoing cardiac surgery from the start of the study ( March 2022) until approximately 2032 Exclusion Criteria: • Patients who object to the re-use of their care data or do not give consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Female<br>Female patients undergoing cardiac surgery | Procedure: Cardiac surgery<br>* Cardiac surgery of all types<br>|
| Male<br>Male patients undergoing cardiac surgery | Procedure: Cardiac surgery<br>* Cardiac surgery of all types<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary endpoint | Incidence of mortality (number of patients) specific (coagulation), transfusion products, anesthesia, surgery and cross-clamp times, etc | up to 30 days post-surgery | 
| Primary endpoint | incidence of cerebrovascualar accident with neurological sequelae (number of patients) | up to 30 days post-surgery | 
| Primary endpoint | incidence of acute kidney injury (number of patients) | up to 30 days post-surgery | 
| Primary endpoint | incidence of low cardiac output syndrome, pulmonary and other complications (requiring ventilation > 48 hours post-operatively) | up to 30 days post-surgery | 
| Primary endpoint | Number of specific (coagulation), transfusion products, | up to 30 days post-surgery | 
| Primary outcome | Times: surgical, cross-clamp, bypass, anesthetic, intensive care admission, hospital admission, etc. | up to 30 days post-surgery or if still in hospital, until discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morbidity and mortality | peroperative and post-operative complications | At 30, 90, 365 days | 
| Survival | Long term survival | At 5 and 10 years | 
| Health related Quality of life measured by PROMS | Long term quality of life after cardiac surgery, measured by Seattle Angina Questionaire (SAQ), EuroQol Quality of life (EQ-5D-5L) and Coronary Revascularisation Outcome Questionnaire (CROQ) or other appropriate questionnaire | At 1, 5 and 10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anesthesia, Quality of Life