The PRE-OP ENERGY Trial (NCT04015973) | Clinical Trial Compass
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The PRE-OP ENERGY Trial
United Kingdom116 participantsStarted 2019-05-07
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 met…
What they're measuring
1
Change of Serum Creatinine level
Timeframe: Baseline, 0-6, 6-12, 24, 48, 72, and up to 96 hours post-operatively
2
Change of Serum Troponin I level
Timeframe: Baseline, 0-6, 6-12, 24, 48 and 72 hours post-operatively