Towards a Sex-specific "Female Enhanced Recovery After Cardiac Surgery'' (F-ERAS) Pathway:

NCT06175650 | Recruiting

• 1 other identifier: W22_051 # 22.082
• Study Type: observational
• Target: 5,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Female; Male; Surgery,Cardiac

Keywords

Anesthesia; Quality of Life

Outcome Measures

Primary Outcomes (6)

• Primary endpoint

  Incidence of mortality (number of patients) specific (coagulation), transfusion products, anesthesia, surgery and cross-clamp times, etc

  up to 30 days post-surgery

• Primary endpoint

  incidence of cerebrovascualar accident with neurological sequelae (number of patients)

  up to 30 days post-surgery

• Primary endpoint

  incidence of acute kidney injury (number of patients)

  up to 30 days post-surgery

• Primary endpoint

  incidence of low cardiac output syndrome, pulmonary and other complications (requiring ventilation \> 48 hours post-operatively)

  up to 30 days post-surgery

• Primary endpoint

  Number of specific (coagulation), transfusion products,

  up to 30 days post-surgery

• Primary outcome

  Times: surgical, cross-clamp, bypass, anesthetic, intensive care admission, hospital admission, etc.

  up to 30 days post-surgery or if still in hospital, until discharge

Secondary Outcomes (3)

• Morbidity and mortality

  At 30, 90, 365 days

• Survival

  At 5 and 10 years

• Health related Quality of life measured by PROMS

  At 1, 5 and 10 years

Study Arms (2)

Female

Female patients undergoing cardiac surgery

Procedure: Cardiac surgery

Male

Male patients undergoing cardiac surgery

Procedure: Cardiac surgery

Interventions

Cardiac surgery PROCEDURE

Cardiac surgery of all types

Female; Male

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Patients who object to the re-use of their care data or do not give consent

Sponsors & Collaborators

• Jennifer Breel: lead

Study Sites (1)

Academic Medical Center

Amsterdam, North Holland, 1105 AZ, Netherlands

RECRUITING

Related Publications (4)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Interventions

Cardiac Surgical Procedures

Intervention Hierarchy (Ancestors)

Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Thoracic Surgical Procedures

Study Officials

• Markus W Hollmann, Professor

  Anesthesiology and Pain Medicine, Amsterdam Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer S Breel, MSc

CONTACT

+31610019257; j.s.breel@amsterdamumc.nl

Susanne Eberl, PhD

CONTACT

+31610019257; s.eberl@amsterdamumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: March 20, 2022
• First Posted: December 19, 2023
• Study Start: November 21, 2023
• Primary Completion: November 21, 2025
• Study Completion (Estimated): November 21, 2026
• Last Updated: December 19, 2023

Record last verified: 2023-12

Locations

NL (1)