Anesthesia, Perfusion, and Surgical practicEs in Cardiac Surgery

NCT ID: NCT07255924

Last Updated: 2025-12-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 15000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2026-04-01
• Study Completion Date: 2036-01-31

Brief Summary

Perioperative management in cardiac surgery, particularly the use of anesthesia, cardiopulmonary bypass (CPB), and surgical techniques, remains highly variable across institutions. Current international guidelines lack clear recommendations due to insufficient high-quality comparative data. APECx is an adaptive, international, multicenter, prospective, observational study designed to address multiple of these evidence gaps. The adaptive design allows the study to proceed through subsequent phases. Each phase will collect comprehensive global data on specific peri-operative practices and their associated patient outcomes, all within a single, continuously evolving study.

Detailed Description

The perioperative management, particularly the use of anesthesia, cardiopulmonary bypass (CPB) and surgical techniques in cardiac surgery, remains highly variable across institutions and regions. Current international guidelines lack clear recommendations due to the insufficiency of high-quality comparative data. Furthermore, over two thirds of the recommendations continue to rely on expert opinion, with little change over time. Given the complexity and physiological burden of cardiac surgery, understanding global variation in anesthetic, perfusion and surgical strategies is critical.

The APECx initiative is an adaptive, international, multicenter, prospective cohort study designed to address multiple of these knowledge gaps. The study aims to promote consistent, evidence-based care by describing global practice variationsand identifying potential modifiable factors that are associated with clinical outcomes.

The core feature of the APECx study is its adaptive design that allows the research focus to evolve over time. The study will proceed through distinct phases, beginning in 2026. Each phase will span approximately one year, concluding once the phase-specific, predefined sample size is reached, at which point the study will transition to the next phase. This framework enables the collection of comprehensive data on specific practices and outcomes within a single, continuously evolving study. To ensure transparency and reproducibility, a detailed protocol for each study phase will be registered on ClinicalTrials.gov prior to phase start.

All data will be prospectively collected by local investigators and entered into a web-based electronic Case Report Form (eCRF) using Castor (Castor Electronic Data Capture, Amsterdam, the Netherlands). Data collection will occur biannually, with participating centers collecting data for a period of two consecutive weeks within a designated three-month window. Follow-up will continue for 30 days post-surgery or until hospital discharge, whichever comes first.

This study will be conducted at cardiac surgery centers worldwide. An inclusive enrollment strategy aims to recruit a broad spectrum of centers, varying in research involvement, surgical complexity, annual caseload, and geographic location, to ensure a globally representative dataset. Centers will have the flexibility to join or leave the study at the beginning of each new phase, a design feature intended to lower the threshold for participation.

Conditions

Cardiac Anaesthesia; Cardiac Surgery; Perfusion; Anesthesia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Phase 1

The Phase 1 cohort comprises all participants enrolled during the first phase of the APECx study. The primary focus for this phase/group is to identify global mechanical ventilation strategies and their associations with key clinical outcomes, including the incidence of post-operative pulmonary complications.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 18 years or older
• Undergoing cardiac surgery at a participating center

Exclusion Criteria

• Transcatheter cardiac interventions or endovascular procedures

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amsterdam UMC, location AMC

OTHER

Sponsor Role: collaborator

VU University of Amsterdam

OTHER

Sponsor Role: collaborator

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

OTHER

Sponsor Role: lead

Responsible Party

Nimrat Grewal

Professor and Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anne M Beukers, MD, PhD

Role: STUDY_CHAIR

Amsterdam UMC

David MP van Meenen, MD, PhD

Role: STUDY_CHAIR

Amsterdam UMC

Locations

Amsterdam UMC, Location AMC

Amsterdam, North Holland, Netherlands

Countries

Netherlands

Central Contacts

Jord C Seegers, MD

Role: CONTACT

apecx@amsterdamumc.nl

+3120 566 9111

Anne M Beukers, MD, PhD

Role: CONTACT

a.beukers@amsterdamumc.nl

Facility Contacts

Jord C Seegers, MD

Role: primary

j.c.seegers@amsterdamumc.nl

+3120 566 9111

References

Belway D, Tee R, Nathan HJ, Rubens FD, Boodhwani M. Temperature management and monitoring practices during adult cardiac surgery under cardiopulmonary bypass: results of a Canadian national survey. Perfusion. 2011 Sep;26(5):395-400. doi: 10.1177/0267659111409095. Epub 2011 May 18.

Reference Type: BACKGROUND

PMID: 21593083 (View on PubMed)

Klein A, Agarwal S, Cholley B, Fassl J, Griffin M, Kaakinen T, Mzallassi Z, Paulus P, Rex S, Siegemund M, van Saet A. A survey of patient blood management for patients undergoing cardiac surgery in nine European countries. J Clin Anesth. 2021 Sep;72:110311. doi: 10.1016/j.jclinane.2021.110311. Epub 2021 Apr 24.

Reference Type: BACKGROUND

PMID: 33905900 (View on PubMed)

Abbott TEF, Fowler AJ, Pelosi P, Gama de Abreu M, Moller AM, Canet J, Creagh-Brown B, Mythen M, Gin T, Lalu MM, Futier E, Grocott MP, Schultz MJ, Pearse RM; StEP-COMPAC Group. A systematic review and consensus definitions for standardised end-points in perioperative medicine: pulmonary complications. Br J Anaesth. 2018 May;120(5):1066-1079. doi: 10.1016/j.bja.2018.02.007. Epub 2018 Mar 27.

Reference Type: BACKGROUND

PMID: 29661384 (View on PubMed)

Authors/Task Force Members:; Jeppsson A; (Co-Chairperson) (Sweden); Rocca B; (Co-Chairperson) (Italy); Hansson EC; (Sweden); Gudbjartsson T; (Iceland); James S; (Sweden); Kaski JC; (United Kingdom); Landmesser U; (Germany); Landoni G; (Italy); Magro P; (Portugal); Pan E; (Finland); Ravn HB; (Denmark); Sandner S; (Austria); Sandoval E; (Spain); Uva MS; (Portugal); Milojevic M; (Serbia); EACTS Scientific Document Group. 2024 EACTS Guidelines on perioperative medication in adult cardiac surgery. Eur J Cardiothorac Surg. 2024 Dec 26;67(1):ezae355. doi: 10.1093/ejcts/ezae355. No abstract available.

Reference Type: BACKGROUND

PMID: 39385505 (View on PubMed)

Authors/Task Force Members; Kunst G, Milojevic M, Boer C, De Somer FMJJ, Gudbjartsson T, van den Goor J, Jones TJ, Lomivorotov V, Merkle F, Ranucci M, Puis L, Wahba A; EACTS/EACTA/EBCP Committee Reviewers; Alston P, Fitzgerald D, Nikolic A, Onorati F, Rasmussen BS, Svenmarker S. 2019 EACTS/EACTA/EBCP guidelines on cardiopulmonary bypass in adult cardiac surgery. Br J Anaesth. 2019 Dec;123(6):713-757. doi: 10.1016/j.bja.2019.09.012. Epub 2019 Oct 2. No abstract available.

Reference Type: BACKGROUND

PMID: 31585674 (View on PubMed)

Other Identifiers

2025.0597

Identifier Type: -

Identifier Source: org_study_id