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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Female; Male; Surgery,Cardiac
• Intervention / Treatment: Procedure: Cardiac surgery

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

• Study Type: Observational
• Enrollment (Estimated): 5500

Contacts and Locations

• Study Contact: Name: Jennifer S Breel, MSc; Phone Number: +31610019257; Email: j.s.breel@amsterdamumc.nl
• Study Contact Backup: Name: Susanne Eberl, PhD; Phone Number: +31610019257; Email: s.eberl@amsterdamumc.nl

Study Locations

• Netherlands
  • North Holland
    • Amsterdam, North Holland, Netherlands, 1105 AZ
      • Recruiting
      • Academic Medical Center
      • Contact: Jennifer S Breel, MPA,MSc.; Phone Number: +316 1001 9257; Email: j.s.breel@amsterdamumc.nl
      • Sub-Investigator: Jennifer S Breel, MPA,MSc.
      • Principal Investigator: Susanne Eberl, MD,PhD
      • Contact: Susanne Eberl, MD, PhD; Phone Number: 62533 +31205669111; Email: s.eberl@amsterdamumc.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Female; Female patients undergoing cardiac surgery	Procedure: Cardiac surgery; Cardiac surgery of all types
Male; Male patients undergoing cardiac surgery	Procedure: Cardiac surgery; Cardiac surgery of all types

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morbidity and mortality	peroperative and post-operative complications	At 30, 90, 365 days
Survival	Long term survival	At 5 and 10 years
Health related Quality of life measured by PROMS	Long term quality of life after cardiac surgery, measured by Seattle Angina Questionaire (SAQ), EuroQol Quality of life (EQ-5D-5L) and Coronary Revascularisation Outcome Questionnaire (CROQ) or other appropriate questionnaire	At 1, 5 and 10 years

Collaborators and Investigators

• Sponsor: Jennifer Breel
• Investigators: Principal Investigator: Markus W Hollmann, Professor, Anesthesiology and Pain Medicine, Amsterdam Medical Center

Publications and helpful links

General 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2023
• Primary Completion (Estimated): November 21, 2025
• Study Completion (Estimated): November 21, 2026

Study Registration Dates

• First Submitted: March 20, 2022
• First Submitted That Met QC Criteria: December 18, 2023
• First Posted (Estimated): December 19, 2023

Study Record Updates

• Last Update Posted (Estimated): December 19, 2023
• Last Update Submitted That Met QC Criteria: December 18, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Quality of Life; Anesthesia
• Other Study ID Numbers: W22_051 # 22.082

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No