The PRE-OP ENERGY Trial

Launched by UNIVERSITY OF LEICESTER · Jul 10, 2019

Keywords

ClinConnect Summary

The PRE-OP ENERGY Trial is studying whether a high-energy diet before heart surgery can help protect patients from organ damage during the procedure. This trial is currently looking for participants who are at least 18 years old and scheduled for specific types of heart surgeries, such as valve repair or bypass surgery. To qualify, participants should have a body mass index (BMI) of less than 30, be able to understand and provide consent in English, and not have certain health conditions, like celiac disease or severe kidney issues.

If you join the trial, you will be asked to follow a special diet before your surgery and will be monitored closely during the process. This research aims to improve patient outcomes and ensure safer surgeries for heart patients. It's important to know that if you have certain medical devices or conditions, you may not be able to participate. If you're interested in contributing to this important study, speak with your healthcare provider to see if you meet the eligibility criteria.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• ALL of the following:
• • Adult cardiac surgery patients (≥18 years) undergoing cardiac surgery (CABG, Valve, or CABG and Valve) with cardiopulmonary bypass.
• • BMI\<30
• • Able, in the opinion of the investigator, and willing to give informed consent.
• • Do not have diagnosed coeliac disease
• • Able to understand English
• Exclusion Criteria:
• Any of the following:
• • Urgent, emergency or salvage procedure
• • Patients with end stage renal failure defined as an estimated Glomerular Filtration rate (eGFR) \<15 mL/min/1.73 m2 calculated from the Modification of Diet in Renal Disease equation,1 or patients who are on long-term haemodialysis or have undergone renal transplantation.
• • Patients with persistent or chronic atrial fibrillation.
• • Patients with severe liver dysfunction; hepatitis, cirrhosis, jaundice.
• • Women who are pregnant or who may become pregnant in the intraoperative period.
• • Patients who are participating in another interventional clinical trial.
• • Unable, in the opinion of the investigator, or unwilling to give informed consent.
• • Have diagnosed coeliac disease
• • Unable to understand English
• Exclusion criteria for optional MRI research procedure:
• • Permanent pacemaker or ICD
• • Brain Aneurysm Clip
• • Implanted neural stimulator
• • Cochlear implant (specific implant must be checked that it is MR safe)
• • Ocular foreign body (e.g. metal shavings) unless removed
• • Other implanted medical devices: (e.g. Swan Ganz catheter)
• • Insulin pump
• • Retained metal shrapnel or bullet
• • Claustrophobia