A pilot study of alternative substrates in the critically Ill subject using a ketogenic feed.
Angela McNellyAnne LanganDanielle E BearAlexandria PageTim MartinFatima SeiduFilipa SantosKieron RooneyKaifeng LiangSimon J HealesTomas BaldwinIsabelle AlldrittHannah CrosslandPhilip J AthertonDaniel WilkinsonHugh MontgomeryJohn ProwleRupert PearseSimon EatonZudin A PuthuchearyPublished in: Nature communications (2023)
Bioenergetic failure caused by impaired utilisation of glucose and fatty acids contributes to organ dysfunction across multiple tissues in critical illness. Ketone bodies may form an alternative substrate source, but the feasibility and safety of inducing a ketogenic state in physiologically unstable patients is not known. Twenty-nine mechanically ventilated adults with multi-organ failure managed on intensive care units were randomised (Ketogenic n = 14, Control n = 15) into a two-centre pilot open-label trial of ketogenic versus standard enteral feeding. The primary endpoints were assessment of feasibility and safety, recruitment and retention rates and achievement of ketosis and glucose control. Ketogenic feeding was feasible, safe, well tolerated and resulted in ketosis in all patients in the intervention group, with a refusal rate of 4.1% and 82.8% retention. Patients who received ketogenic feeding had fewer hypoglycaemic events (0.0% vs. 1.6%), required less exogenous international units of insulin (0 (Interquartile range 0-16) vs.78 (Interquartile range 0-412) but had slightly more daily episodes of diarrhoea (53.5% vs. 42.9%) over the trial period. Ketogenic feeding was feasible and may be an intervention for addressing bioenergetic failure in critically ill patients. Clinical Trials.gov registration: NCT04101071.
Keyphrases
- clinical trial
- open label
- end stage renal disease
- study protocol
- intensive care unit
- randomized controlled trial
- phase ii
- ejection fraction
- newly diagnosed
- chronic kidney disease
- type diabetes
- prognostic factors
- squamous cell carcinoma
- oxidative stress
- fatty acid
- gene expression
- acute respiratory distress syndrome
- metabolic syndrome
- blood pressure
- insulin resistance
- double blind
- physical activity
- patient reported outcomes
- weight loss
- blood glucose
- extracorporeal membrane oxygenation
- locally advanced
- skeletal muscle
- patient reported
- phase ii study
- clinical evaluation