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NCT Number: NCT07255924

Anesthesia, Perfusion, and Surgical practicEs in Cardiac Surgery

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.

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Key information

Conditions

Cardiac Anaesthesia Anesthesia Cardiac Surgery Perfusion

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Transcatheter cardiac interventions or endovascular procedures

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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

  6. 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.

  7. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Anne M Beukers, MD, PhD

CONTACT

[email protected]

Jord C Seegers, MD

CONTACT

[email protected]

+3120 566 9111

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Amsterdam UMC, location AMC
  • VU University of Amsterdam

Registry information

Official study title

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

Acronym: APECx

Important dates

Study start
2026
Primary completion
2036
Study completion
2036
First posted
Dec 1, 2025
Registry last updated
Dec 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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