Anesthesia, Perfusion, and Surgical practicEs in Cardiac Surgery

Condition(s) studied

Study 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.

Eligibility

Primary outcome measure(s)

• Hospital length of stay — 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.
• Intensive Care Unit (ICU) length of stay — 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.
• All-cause in-hospital 30-day mortality — 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.
• Postoperative pulmonary complications — 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.
• Duration of mechanical ventilation — 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.

Trial sites (1)

More Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) trials in the Netherlands

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