Table 2.

Potential complications according to high-risk patient populations, with the corresponding appropriate clinical monitoring and interventions.

Potential Complication	High Risk Patient Population	Clinical and Investigational Monitoring	Possible Intervention to Reduce Complication
Nausea, vomiting, worsening of reflux disease	Young infants, Multiple AED, GERD, Hypotonia	-Serial urine ketones, blood glucose -BHB -Weight -GI consultation	-Anti-reflux medication (e.g., PPI) -Anti-nausea medication (e.g., Ondansetron) -Treat constipation if necessary -Positioning while feeding -Changing formula type/consisting in G-tube and changing time of various medications in relation to diet administration -Small bolus or continuous feeding
Constipation	Prior h/o constipation, Autism, Hypotonia and GDDYoung infants	-Formal GI consultation and serial monitoring	-Senna -Miralax -Feeding schedule -Biofeedback therapy
Weight loss	Low BMI before KD initiation, Genetic epilepsy, GDD, Use of ASM such as Topiramate	-Serial weight monitoring	-Use of higher calories and MCT-based diet to maintain ketosis and improve weight -Avoid Topiramate if possible
Osteopenia	Poor bone density, Low Vit D, Prior h/o fractures, h/o genetic condition such as Osteogenic imperfecta	-Serial Vit D level -Serial Dexascan -Endocrine evaluation	-Vit D replacement -Adequate sunlight exposure -Biphosphonates under endocrinology supervision
Persistently Low ASM levels	Use of Multiple ASM, including enzyme-inducing ASM	-Serial ASM monitoring	-Optimize dose as tolerated for low ASM levels -Avoid multiple ASMs that interact with each other’s metabolism, and avoid enzyme inducing ASMs
Hypoglycemia	Infants, Low BMI, High KD ratio H/o vomiting and poor feeding tolerance, Surgical procedures	-Serial blood glucose monitoring q6H and PRN -Small and continuous feeding	-Small quantity of orange juice PRN -Lower KD ratio if necessary
Carnitine deficiency	Prior low carnitine levels, Use of High KD ratio, Use of ASM such as Valproic acid	-Serial monitoring levels of Carnitine profile -Monitor clinical symptoms such as fatigue, tiredness, abnormal LFTs	-Supplement Levocarnitine 50–100 mg/kg/day in tablet form, if symptomatic
Hyperlipidemia	Family h/o hyperlipidemias, High BMI, Type II DM, High KD ratio	-Serial fasting lipid profile	-Low use of trans and saturated fat KD -Increase polyunsaturated and monounsaturated fat -Carnitine replacement -Physical exercise
Renal stones	Infants, H/o prematurity, H/o renal malformation, High KD ratio, Concurrent use of ASM such as Topiramate, Family h/o renal stones	-Serial urine calcium/creatinine -Serial renal USG -Serial BHB level -Nephrology and urology consultation before and after initiation of KD	-Avoid ASMs such as Topiramate -Lower KD ratio -Use urine alkalization medications such as Polycitra-K®
Acidosis	Infants, High KD ratio, Concurrent use of ASM such as Topiramate	-Serial BMP	-Use of baking soda or sodium bicarbonate tablets or -Polycitra-K® (2 meq/kg/day) -Lower KD ratio if necessary