Anesthesia, Perfusion, and Surgical practicEs in Cardiac Surgery (APECx)

November 27, 2025 updated by: Nimrat Grewal, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Anesthesia, Perfusion, and Surgical practicEs in Cardiac Surgery: an Adaptive, Prospective, International, Multicenter, Observational Study.

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.

Study Overview

Status

Not yet recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

15000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Netherlands
    • North Holland
      • Amsterdam, North Holland, Netherlands, 1105AZ

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adults undergoing cardiac surgery at one of the participating centers.

Description

Inclusion Criteria:

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

Exclusion Criteria:

- Transcatheter cardiac interventions or endovascular procedures

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital length of stay
Time Frame: From date of cardiac surgery until hospital discharge, assessed up to 30 days postoperatively.
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
Time Frame: From the time of ICU admission immediately after cardiac surgery until transfer out of the ICU, assessed up to 30 days postoperatively.
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
Time Frame: From the date of surgery until death, assessed up to 30 days postoperatively.
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
Time Frame: Directly after cardiac surgery until the fifth postoperative day.
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
Time Frame: From the initiation of mechanical ventilation until the first discontinuation of mechanical ventilation, assessed up to 30 days postoperatively.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute Kidney Injury (AKI)
Time Frame: Directly after cardiac surgery up to 30 days postoperatively.
Incidence of Acute Kidney Injury as defined by the KDIGO 2012 criteria.
Directly after cardiac surgery up to 30 days postoperatively.
Postoperative stroke
Time Frame: Directly after cardiac surgery up to 30 days postoperatively.
Post-operative stroke is defined as a cerebrovascular event (either ischemic or hemorrhagic) occurring within 30 days following cardiac surgery. The diagnosis is based on the onset of neurological deficits that may be temporary or persist long term, with confirmation via neuroimaging (CT or MRI) when possible.
Directly after cardiac surgery up to 30 days postoperatively.
Need for cardiac mechanical circulatory and/or cardiac, respiratory or cardiorespiratory extracorporeal life support modalities
Time Frame: Directly after cardiac surgery up to 30 days postoperatively.
The incidence of postoperative use of cardiac mechanical circulatory (e.g. intra-aortic balloon pump, Impella) and/or cardiac, respiratory or cardiorespiratory extracorporeal life support (ECLS) modalities.
Directly after cardiac surgery up to 30 days postoperatively.
Postoperative Myocardial Infarction
Time Frame: Directly after cardiac surgery up to 30 days postoperatively.
Postoperative myocardial infarction is a heart attack that occurs within the 30 days following cardiac surgery. The diagnosis requires evidence of new myocardial injury, primarily detected by an elevation in cardiac troponin or Creatine Kinase MB (CK-MB) levels, along with other clinical signs of ischemia like specific ECG changes or new wall motion abnormalities on imaging.
Directly after cardiac surgery up to 30 days postoperatively.
New-onset postoperative atrial fibrilliation
Time Frame: Directly after cardiac surgery up to 30 days postoperatively.
New-onset postoperative atrial fibrillation is the development of atrial fibrillation within the first 30 days following cardiac surgery in participants who were not previously diagnosed with atrial fibrillation
Directly after cardiac surgery up to 30 days postoperatively.
Postoperative chest tube bloodloss
Time Frame: Measured in the first 12 hours after cardiac surgery
Postoperative chest tube blood loss is the measured volume of blood drained from the chest cavity through surgically placed tubes following cardiac surgery.
Measured in the first 12 hours after cardiac surgery
Postoperative transfustion rates
Time Frame: Directly after cardiac surgery up to 30 days postoperatively.
Defined as the number of units of erythrocytes (red blood cells), thrombocytes (platelets), and fresh frozen plasma (FFP) postoperatively transfused to each participant.
Directly after cardiac surgery up to 30 days postoperatively.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

VU University of Amsterdam
Amsterdam UMC, location AMC

Investigators

  • Study Chair: Anne M Beukers, MD, PhD, Amsterdam UMC
  • Study Chair: David MP van Meenen, MD, PhD, Amsterdam UMC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

January 1, 2036

Study Completion (Estimated)

January 1, 2036

Study Registration Dates

First Submitted

November 14, 2025

First Submitted That Met QC Criteria

November 27, 2025

First Posted (Actual)

December 1, 2025

Study Record Updates

Last Update Posted (Actual)

December 1, 2025

Last Update Submitted That Met QC Criteria

November 27, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2025.0597

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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