The goal of this observational study is to learn whether metabolic inflexibility, which means reduced ability of the body to switch between using fats and sugars for energy, is associated with myocardial injury after non-cardiac surgery (MINS) in adults undergoing major elective abdominal cancer surgery.
The main question it aims to answer is:
Does pre-operative metabolic inflexibility predict myocardial injury after non-cardiac surgery (MINS) within the first 72 hours after surgery?
Participants will continue with their usual surgical care and pre-planned CPET (which can measure metabolic flexibility). As part of the study, participants will:
* Have additional blood samples taken before and after surgery * Have an echocardiogram and, where possible, muscle ultrasound * Wear a wrist-worn activity monitor before surgery * Have routine clinical and surgical information collected from their medical records * Receive a follow-up phone call around 90 days after surgery
Adults aged 18 or over
Scheduled for major elective abdominal cancer surgery with planned overnight admission
Scheduled for pre-operative CPET
Able to provide written informed consent
Less than 18 years old
Emergency surgery
Unable or unwilling to undergo CPET
Pregnancy
Participants will be selected from patients receiving care at University College London Hospitals and other participating CIPHER-2 network hospitals, including Southampton and Plymouth. Potential participants will be identified through perioperative/pre-operative assessment pathways, including routine cardiopulmonary exercise testing clinics for patients being assessed before major surgery.
Cohort
Prospective
Pre-operative Metabolic Inflexibility
Other interventionPre-operative metabolic inflexibility will be assessed as an observational exposure using data from routine pre-operative cardiopulmonary exercise testing (CPET). CPET-derived measures of substrate utilisation, including fat and carbohydrate oxidation, will be used to evaluate the participant's ability to switch between energy sources during physiological stress. Additional blood-based metabolic, immune, and cardiac biomarker analyses may be used to further characterise metabolic phenotype. No treatment, procedure, or clinical management will be assigned or altered by the study.
Development of Myocardial Injury after Non-Cardiac Surgery
The primary outcome is the number of participants who develop myocardial injury after non-cardiac surgery (MINS) within 72 hours after surgery. MINS means evidence of heart muscle injury after an operation that is not heart surgery. It will be assessed using blood tests for high-sensitivity cardiac troponin I, a protein that is released into the blood when the heart muscle is injured. Blood samples will be taken on postoperative days 1, 2, and 3. Participants will be classified as having MINS if their postoperative troponin result is above the study-defined threshold for myocardial injury and the injury is judged to be related to the perioperative period rather than another clear non-surgical cause.
Clavien-Dindo Complication Grade
Postoperative complications will be classified using the Clavien-Dindo grading system, which grades complications according to the treatment required to manage them. Higher grades indicate more serious complications. The outcome will report the number of participants with major postoperative morbidity, defined as a Clavien-Dindo grade III or higher complication.
Post-Operative Morbidity Survey (POMS)
Postoperative morbidity will be assessed using the Postoperative Morbidity Survey (POMS), a structured assessment that records whether participants have complications affecting different organ systems after surgery. The outcome will report the number of participants with postoperative morbidity identified by POMS assessment.
Length of Hospital Stay
Length of hospital stay will be measured as the number of days from the date of surgery to the date the participant is discharged from hospital. This outcome will describe how long participants remain in hospital after their operation.
Days Alive and Out of Hospital at 90 Days
Days alive and out of hospital at 90 days, also known as DAOH90, will be measured as the number of days the participant is alive and not admitted to hospital during the first 90 days after surgery. This outcome reflects postoperative recovery by combining survival, length of initial hospital stay, and any hospital readmissions within 90 days.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
