SEx-specific Differences in Cardiac Surgery Patients (SECS).

NCT ID: NCT06554925

Last Updated: 2024-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

10000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-01

Study Completion Date

2031-03-01

Brief Summary

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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

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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.

Conditions

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Female Male Surgery, Cardiac

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Female

Female sex undergoing cardiac surgery

Cardiac surgery

Intervention Type PROCEDURE

The difference in males and females undergoing cardiac surgery of all types

Male

Male sex undergoing cardiac surgery

Cardiac surgery

Intervention Type PROCEDURE

The difference in males and females undergoing cardiac surgery of all types

Interventions

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Cardiac surgery

The difference in males and females undergoing cardiac surgery of all types

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jennifer Breel

OTHER

Sponsor Role lead

Responsible Party

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Jennifer Breel

Research coordinator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Markus W Hollmann, Professor

Role: PRINCIPAL_INVESTIGATOR

Anesthesiology and Pain Medicine, Amsterdam Medical Center

Locations

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Academic Medical Center

Amsterdam, North Holland, Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Jennifer S Breel, MSc

Role: CONTACT

+31610019257

Susanne Eberl, PhD

Role: CONTACT

+31610019257

Facility Contacts

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Jennifer S Breel, MSc.

Role: primary

+31610019257

Susanne Eberl, MD,PhD

Role: backup

+31610019257

References

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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.

Reference Type BACKGROUND
PMID: 34606298 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34520795 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34776353 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34524421 (View on PubMed)

Other Identifiers

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W22_050 # 22.081

Identifier Type: -

Identifier Source: org_study_id

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