Status:
UNKNOWN
The PRE-OP ENERGY Trial
Lead Sponsor:
University of Leicester
Conditions:
Cardiac Valve Disease
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The PRE-OP ENERGY Trial proposes to test the overarching hypothesis that a pre-surgery high energy diet will protect patients against organ damage during cardiac surgery with cardiopulmonary bypass.
Detailed Description
PRE-OP ENERGY is a single centre, unblinded, parallel group, randomised controlled trial of a pre-operative high energy diet, versus a control group receiving standard care. The trial will test a num...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 7 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 7 2024
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT04015973
Start Date
May 7 2019
End Date
October 7 2024
Last Update
November 7 2023
Active Locations (1)
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1
University of Leicester
Leicester, Leicestershire, United Kingdom, LE3 9QP