Anesthesia, Perfusion, and Surgical practicEs in Cardiac Surgery

NCT07255924 | Not Yet Recruiting

• 1 other identifier: 2025.0597
• Study Type: observational
• Target: 15,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Anaesthesia; Cardiac Surgery; Perfusion; Anesthesia

Keywords

Cardiac Surgery; Cardiac Anaesthesia; Anesthesia; Perfusion

Outcome Measures

Primary Outcomes (5)

• Hospital length of stay

  Hospital length of stay (LOS) refers to the total duration (in days) of a patient's admission in the hospital.

  From date of cardiac surgery until hospital discharge, assessed up to 30 days postoperatively.

• Intensive Care Unit (ICU) length of stay

  Intensive Care Unit (ICU) length of stay (LOS) is the duration (in days) a participant spends postoperatively in the ICU.

  From the time of ICU admission immediately after cardiac surgery until transfer out of the ICU, assessed up to 30 days postoperatively.

• All-cause in-hospital 30-day mortality

  All-cause in-hospital 30-day mortality refers to death from any cause during the hospital stay within 30 days after cardiac surgery.

  From the date of surgery until death, assessed up to 30 days postoperatively.

• Postoperative pulmonary complications

  Postoperative pulmonary complications (PPCs) are a composite of pulmonary events occurring within the first 5 postoperative days, including: - Mild respiratory failure: SpO₂ \<90% or PaO₂ \<7.9 kPa on room air, increased oxygen need, or oxygen use \>2 days; - Severe respiratory failure: ventilatory support or hypoxemia despite oxygen; - Bronchospasm: new wheeze treated with bronchodilator; - Suspected infection: antibiotics plus new sputum, opacities, fever \>38.3°C, or WBC \>12,000/μL; - Pulmonary infiltrate: any unilateral or bilateral infiltrates on chest X-ray; - Aspiration pneumonitis: respiratory failure following inhalation of gastric contents; - Atelectasis: opacification with mediastinal shift and compensatory overinflation; - ARDS: as per global 2023 definition; - Pleural effusion: blunted costophrenic angle or hazy opacity; - Cardiopulmonary edema: congestion signs and interstitial infiltrates; and - Pneumothorax: air in pleural space with absent vascular markings.

  Directly after cardiac surgery until the fifth postoperative day.

• Duration of mechanical ventilation

  Total duration (in hours) a patient peri-operatively receives support form a mechanical ventilator. Defined as the time (in hours) from intubation to the first extubation.

  From the initiation of mechanical ventilation until the first discontinuation of mechanical ventilation, assessed up to 30 days postoperatively.

Secondary Outcomes (7)

• Acute Kidney Injury (AKI)

  Directly after cardiac surgery up to 30 days postoperatively.

• Postoperative stroke

  Directly after cardiac surgery up to 30 days postoperatively.

• Need for cardiac mechanical circulatory and/or cardiac, respiratory or cardiorespiratory extracorporeal life support modalities

  Directly after cardiac surgery up to 30 days postoperatively.

• Postoperative Myocardial Infarction

  Directly after cardiac surgery up to 30 days postoperatively.

• New-onset postoperative atrial fibrilliation

  Directly after cardiac surgery up to 30 days postoperatively.

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults undergoing cardiac surgery at one of the participating centers.

You may qualify if:

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

You may not qualify if:

• \- Transcatheter cardiac interventions or endovascular procedures

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead
• Amsterdam UMC, location AMC: collaborator
• VU University of Amsterdam: collaborator

Study Sites (1)

Amsterdam UMC, Location AMC

Amsterdam, North Holland, 1105AZ, Netherlands

Location

Related Publications (5)

• 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.

  PMID: 21593083 BACKGROUND

• 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.

  PMID: 33905900 BACKGROUND

• 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.

  PMID: 29661384 BACKGROUND

• 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.

  PMID: 39385505 BACKGROUND

• 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.

  PMID: 31585674 BACKGROUND

Study Officials

• Anne M Beukers, MD, PhD

  Amsterdam UMC

  STUDY CHAIR

• David MP van Meenen, MD, PhD

  Amsterdam UMC

  STUDY CHAIR

Central Study Contacts

Jord C Seegers, MD

CONTACT

+3120 566 9111; apecx@amsterdamumc.nl

Anne M Beukers, MD, PhD

CONTACT

a.beukers@amsterdamumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Principal Investigator

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: December 1, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): January 1, 2036
• Study Completion (Estimated): January 1, 2036
• Last Updated: December 1, 2025

Record last verified: 2025-11

Locations

NL (1)