Table 4 Feasibility and safety outcome measures
From: A pilot study of alternative substrates in the critically Ill subject using a ketogenic feed
Endpoint | Tool/method (reference) | Objective |
|---|---|---|
A) Patient recruitment | From screening clinical records, medical history, demographic information; informed consent; randomisation | Feasibility of recruiting to a trial of ketogenic enteral feeding |
B) Modular feed preparation (in ICU) to meet dietician-prescribed nutritional targets | Staff questionnaire | Feasibility of preparation of modular feed on ICUs |
C) Administration of feed | Staff questionnaire | Feasibility of giving ketogenic feed |
D) Glucose and lactate measurements | Point-of-care tests; routine biochemistry | Feasibility of glucose and lactose control |
E) EQ-5D-5L questionnaire | Completed by NOK proxy either in-person or via telephone | Feasibility of determining quality of life at baseline, 3-, 6- and 12 months |
F) Energy and protein intake | From feed recipe and volume administered | Delivery of adequate energy and protein target |
G) Blood gases; biochemistry | Routine biochemistry analysis of blood and urine samples | Safety of ketogenic feed |
H) Serious Adverse Events/Adverse Events | Measures of Gastric intolerance: Gastric Residual Volume; diarrhoea; vomiting; use of pro-kinetics; daily blood glucose levels | Feeding intolerance; abnormal glucose control; other Adverse Events |
I) Muscle mass | RFCSA measurements | Feasibility of bedside ultrasound scans |
J) Functional tests | Physiotherapy assessments: CPAx; 6-MWD; SPPB | Effect on physical function |
K) Levels of ketone bodies, pyruvate, medium/long chain fatty acids and metabolites | GCMS and HPLC analysis of plasma samples | Induction of ketosis within study period; effect on nutrient metabolism |
L) Blood urea levels in plasma | Plasma samples | Effect on protein metabolism |
M) Indirect calorimetry | Calorimeter | Effect on basal metabolic rate |
N) Completion of CRF | Review of medical records | Feasibility of collecting data |
