Clinical trial NCT06554925: SEx-specific Differences in Cardiac Surgery Patients (SECS).
Official title: SEx-specific Differences in Cardiac Surgery Patients (SECS). A Retrospective 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
sex-specific differences
cardiac surgery
care pathways
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2024-08-15
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
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 cardiothoracic surgery from 1998 in the AUMC, location VUmc until June 2021. Observational retrospective data collection from the mandatory Quality Assurance database of the Netherlands Heart Registry, supplemented with data from the electronic patient files (EPIC).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative mortality
timeFrame: Measured at 20 years postoperatively
measure: Postoperative mortality
timeFrame: Measured at 30 days postoperatively
measure: Postoperative mortality
timeFrame: Measured at 1 year postoperatively
measure: Postoperative mortality
timeFrame: Measured at 5 years postoperatively
Secondary outcomes:
measure: Postoperative complications (Morbidity)
timeFrame: Measured at 30 days
measure: Postoperative complications (Morbidity)
timeFrame: Measured at 90 days
measure: Postoperative complications (Morbidity)
timeFrame: Measured at 365 days
measure: Development of a predictive risk score using a composite outcome
timeFrame: Up to 30 days postoperatively
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.