Clinical trial NCT06175650: Towards a Sex-specific "Female Enhanced Recovery After Cardiac Surgery'' (F-ERAS) Pathway:
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Female
Male
Surgery,Cardiac
Keywords: Anesthesia
Quality of Life
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2023-12-19
Enrollment: 5500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of male and female patients, 18 years and older. The study group consists of all patients who underwent cardiac surgery from 1 January 2016 onwards, in either of the centres (AMC or VUmc). The registry will continue for at least 10 years after the inclusion of the last patient.

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

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

Primary outcomes:
measure: Primary endpoint
timeFrame: up to 30 days post-surgery
measure: Primary endpoint
timeFrame: up to 30 days post-surgery
measure: Primary endpoint
timeFrame: up to 30 days post-surgery
measure: Primary endpoint
timeFrame: up to 30 days post-surgery
measure: Primary endpoint
timeFrame: up to 30 days post-surgery
measure: Primary outcome
timeFrame: up to 30 days post-surgery or if still in hospital, until discharge
Secondary outcomes:
measure: Morbidity and mortality
timeFrame: At 30, 90, 365 days
measure: Survival
timeFrame: At 5 and 10 years
measure: Health related Quality of life measured by PROMS
timeFrame: At 1, 5 and 10 years
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Academic Medical Center
state: North Holland
Study officials:
affiliation: Anesthesiology and Pain Medicine, Amsterdam Medical Center
name: Markus W Hollmann, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.