Towards a Sex-specific "Female Enhanced Recovery After Cardiac Surgery'' (F-ERAS) Pathway:
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cardiac surgery.
- Who it may be relevant to
- Registry conditions: Female, Male, Surgery,Cardiac. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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
- Procedure Cardiac surgery
Cardiac surgery of all types
Primary outcome measures
- Primary endpoint [Time frame: up to 30 days post-surgery]
- Primary endpoint [Time frame: up to 30 days post-surgery]
- Primary endpoint [Time frame: up to 30 days post-surgery]
- Primary endpoint [Time frame: up to 30 days post-surgery]
- Primary endpoint [Time frame: up to 30 days post-surgery]
- Primary outcome [Time frame: up to 30 days post-surgery or if still in hospital, until discharge]
Secondary outcome measures (3)
- Morbidity and mortality [Time frame: At 30, 90, 365 days]
- Survival [Time frame: At 5 and 10 years]
- Health related Quality of life measured by PROMS [Time frame: At 1, 5 and 10 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
Netherlands · 1 center
- Academic Medical Center — Amsterdam
Publications
- Cho L, Kibbe MR, Bakaeen F, Aggarwal NR, Davis MB, Karmalou T, Lawton JS, Ouzounian M, Preventza O, Russo AM, Shroyer AW, Zwischenberger BA, Lindley KJ. Cardiac Surgery in Women in the Current Era: What Are the Gaps in Care? Circulation. 2021 Oct 5;144(14):1172-1185. doi: 10.1161/CIRCULATIONAHA.121.056025. Epub 2021 Oct 4. PMID 34606298
- Dixon LK, Di Tommaso E, Dimagli A, Sinha S, Sandhu M, Benedetto U, Angelini GD. Impact of sex on outcomes after cardiac surgery: A systematic review and meta-analysis. Int J Cardiol. 2021 Nov 15;343:27-34. doi: 10.1016/j.ijcard.2021.09.011. Epub 2021 Sep 11. PMID 34520795
- Nanegrungsunk D, Patel S, Jan T, Ngai JY. Preoperative Care Practice for Female Cardiac Patients: A Survey From the Society of Cardiovascular Anesthesiologists. J Cardiothorac Vasc Anesth. 2022 Mar;36(3):920-921. doi: 10.1053/j.jvca.2021.09.054. Epub 2021 Oct 3. No abstract available. PMID 34776353
- Peters SAE, Kluin J. Why do women do worse after coronary artery bypass grafting? Eur Heart J. 2021 Dec 28;43(1):29-31. doi: 10.1093/eurheartj/ehab617. No abstract available. PMID 34524421
Identifiers
NCT: NCT06175650 · W22_051 # 22.082