Personalized cardiac anaesthesia and its effects on neurological outcomes in heart surgery patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This international, multicentre prospective cohort study aims to evaluate the relationship between the duration and magnitude of mean arterial pressure (MAP) outside of individual cerebral autoregulation limits and adverse neurological events in patients undergoing cardiac surgery. Utilizing non-invasive techniques such as near-infrared spectroscopy (NIRS) and transcranial Doppler (TCD), the study will monitor blood pressure tailored to individual characteristics to potentially reduce complications. Additionally, it will explore biological associations between neurological outcomes, neurobiomarkers, and genetic factors to enhance understanding and improve patient safety and quality of life.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Elective primary or reoperative coronary artery bypass graft and/or valvular and/or ascending aorta surgery requiring cardiopulmonary bypass.

Exclusion Criteria:

* Surgery requiring moderate (28-31.9ºC) or deep (\<28ºC) hypothermic circulatory arrest;
* Heart and/or lung transplantation;
* Urgent (within 24 hours) and emergency surgery;
* Inability to follow procedures or insufficient knowledge in English, German or French;
* Inability to give consent.

Participants who undergo cardiac surgery under minimal extracorporeal circulation will also be excluded.

Where it's running

• Inselspital, Bern University Hospital
  Bern, Switzerland Recruiting
• Clinic for Anaesthesia, Intermediate Care, Prehospital Emergency Medicine and Pain Therapy, University Hospital Basel
  Basel, Switzerland Completed
• Cambridge University Hospitals and Brain Physics Lab
  Cambridge, United Kingdom Completed
• Royal Papworth Hospital, Department of Anaesthesia and Intensive Care
  Cambridge, United Kingdom Completed

Study contacts

• Principal investigator: Nuno V. Gomes, MD — Clinic for Anaesthesia, Intermediate Care, Prehospital Emergency Medicine and Pain Therapy, University Hospital Basel
• Study coordinator: Nuno V. Gomes, MD
• Email: nuno.gomes@usb.ch
• Phone: +41 61 328 64 46

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.