Anesthesia, Perfusion, and Surgical practicEs in Cardiac Surgery
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18 years or older
Undergoing cardiac surgery at a participating center
Disqualifiers
None
Trial population
Adults undergoing cardiac surgery at one of the participating centers.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
15,000 Participants
are grouped into 1 trial groupGroup A: Phase 1
Trial outcomes
Primary outcomes
1
Hospital length of stay
Hospital length of stay (LOS) refers to the total duration (in days) of a patient's admission in the hospital.
Time frame
From date of cardiac surgery until hospital discharge, assessed up to 30 days postoperatively.2
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.
Time frame
From the time of ICU admission immediately after cardiac surgery until transfer out of the ICU, assessed up to 30 days postoperatively.3
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.
Time frame
From the date of surgery until death, assessed up to 30 days postoperatively.4
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.
Time frame
Directly after cardiac surgery until the fifth postoperative day.Secondary outcomes
1
Acute Kidney Injury (AKI)
Incidence of Acute Kidney Injury as defined by the KDIGO 2012 criteria.
Time frame
Directly after cardiac surgery up to 30 days postoperatively.2
Postoperative stroke
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.
Time frame
Directly after cardiac surgery up to 30 days postoperatively.3
Need for cardiac mechanical circulatory and/or cardiac, respiratory or cardiorespiratory extracorporeal life support modalities
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.
Time frame
Directly after cardiac surgery up to 30 days postoperatively.4
Postoperative Myocardial Infarction
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.
Time frame
Directly after cardiac surgery up to 30 days postoperatively.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Lead sponsor
Amsterdam UMC, location AMC
Collaborator
VU University of Amsterdam
Collaborator
Source ClinicalTrials.gov
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