Female, Male, Surgery,Cardiac
Conditions
Keywords
Anesthesia, Quality of Life
Brief summary
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
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
Interventions
PROCEDURECardiac surgery
Cardiac surgery of all types
Sponsors
Jennifer Breel
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary endpoint | up to 30 days post-surgery | Incidence of mortality (number of patients) specific (coagulation), transfusion products, anesthesia, surgery and cross-clamp times, etc |
| Primary outcome | up to 30 days post-surgery or if still in hospital, until discharge | Times: surgical, cross-clamp, bypass, anesthetic, intensive care admission, hospital admission, etc. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Morbidity and mortality | At 30, 90, 365 days | peroperative and post-operative complications |
| Survival | At 5 and 10 years | Long term survival |
| Health related Quality of life measured by PROMS | At 1, 5 and 10 years | 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 |
Countries
Netherlands
Contacts
Primary ContactJennifer S Breel, MSc
Backup ContactSusanne Eberl, PhD
Outcome results
None listed