FemaleSECSNCT06554925
SEx-specific Differences in Cardiac Surgery Patients (SECS).
An observational study of Female and Male, run by Jennifer Breel at 1 site in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Female, Male, Surgery, Cardiac
- What is being tested?
- Cardiac surgery
- Type of treatment
- Surgery or procedure
- How many people
- 10,000 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Mar 2022to 1 Mar 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- Patients > 18 years
- All patients who underwent cardiac surgery from 1 January 1998 in the AUMC, location VUmc, until 1 June 2021.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Academic Medical Center
Amsterdam, North Holland, 1105AZ
Jennifer S Breel, MSc., +31610019257, j.s.breel@amsterdamumc.nl
Susanne Eberl, MD,PhD, +31610019257, s.eberl@amsterdamumc.nl
About this study
Official title: SEx-specific Differences in Cardiac Surgery Patients (SECS). A Retrospective Registration and Evaluation of Characteristics and Perioperative Management of Cardiac Surgery Patients
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).
Read the 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.
- Conditions
- Female, Male, Surgery, Cardiac
- Being tested
- Cardiac surgery
- Keywords
- anesthesia, sex-specific differences, cardiac surgery, care pathways
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac surgeryProcedure or surgery
The difference in males and females undergoing cardiac surgery of all types
| Study group | Role | What they receive |
|---|---|---|
| Female | Female sex undergoing cardiac surgery Receives: Procedure: Cardiac surgery | |
| Male | Male sex undergoing cardiac surgery Receives: Procedure: Cardiac surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative mortality
Incidence of perioperative mortality
Measured: Measured at 20 years postoperatively
Postoperative mortality
Incidence of perioperative mortality
Measured: Measured at 30 days postoperatively
Postoperative mortality
Incidence of perioperative mortality
Measured: Measured at 1 year postoperatively
Postoperative mortality
Incidence of perioperative mortality
Measured: Measured at 5 years postoperatively
Secondary outcomes (4)
Postoperative complications (Morbidity)
Incidence of peroperative and post-operative complications
Measured: Measured at 30 days
Postoperative complications (Morbidity)
Incidence of peroperative and post-operative complications
Measured: Measured at 90 days
Postoperative complications (Morbidity)
Incidence of peroperative and post-operative complications
Measured: Measured at 365 days
Development of a predictive risk score using a composite outcome
Predictive risk score
Measured: Up to 30 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2024
- Study start1 Mar 2022
- Primary completion1 Mar 2030 (estimated)
- Study completion1 Mar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jennifer Breel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jennifer Breel, Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)
- Investigators
- Markus W Hollmann, Professor, Principal investigator, Anesthesiology and Pain Medicine, Amsterdam Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06554925
- Sponsor's protocol ID
- W22_050 # 22.081
- Acronym
- SECS
- Status last verified
- Aug 2024
- First submitted
- 20 Mar 2022
- Last updated
- 15 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 34606298Dixon 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.
PubMed 34520795Nanegrungsunk 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.
PubMed 34776353Peters 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.
PubMed 34524421
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SEx-specific Differences in Cardiac Surgery Patients (SECS). A Retrospective Registration and Evaluation of Characteristics and Perioperative Management of Cardiac Surgery Patients
- ClinicalTrials.gov ID
- NCT06554925
- Acronym / sponsor ID
- SECS / W22_050 # 22.081
- Conditions
- Female, Male, Surgery, Cardiac
- Keywords
- anesthesia, sex-specific differences, cardiac surgery, care pathways
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Jennifer BreelUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 Mar 2030 (estimated)
- Study completion
- 1 Mar 2031 (estimated)
- First posted
- 15 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Female | – | Procedure: Cardiac surgeryFemale sex undergoing cardiac surgery |
| Male | – | Procedure: Cardiac surgeryMale sex undergoing cardiac surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (2 listed)
- Patients > 18 years
- All patients who underwent cardiac surgery from 1 January 1998 in the AUMC, location VUmc, until 1 June 2021.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac surgeryThe difference in males and females undergoing cardiac surgery of all types | Procedure or surgery | Female, Male |
Primary outcome
Postoperative mortality
Time frame: Measured at 20 years postoperatively
Incidence of perioperative mortality
Postoperative mortality
Time frame: Measured at 30 days postoperatively
Incidence of perioperative mortality
Postoperative mortality
Time frame: Measured at 1 year postoperatively
Incidence of perioperative mortality
Postoperative mortality
Time frame: Measured at 5 years postoperatively
Incidence of perioperative mortality
4 secondary outcomes
Postoperative complications (Morbidity)
Time frame: Measured at 30 days
Postoperative complications (Morbidity)
Time frame: Measured at 90 days
Postoperative complications (Morbidity)
Time frame: Measured at 365 days
Development of a predictive risk score using a composite outcome
Time frame: Up to 30 days postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2024.
- Background: PubMed 34606298Cho 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.
- Background: PubMed 34520795Dixon 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.
- Background: PubMed 34776353Nanegrungsunk 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.
- Background: PubMed 34524421Peters 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Markus W Hollmann, Professor principal investigator
Anesthesiology and Pain Medicine, Amsterdam Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Female and Male, run by Jennifer Breel at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer S Breel, MSc (+31610019257, j.s.breel@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative mortality (time frame: Measured at 20 years postoperatively). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06554925, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2024.