The purpose of this study is to determine the efficacy and safety of a diabetes-specific tube feed in comparison to an isocaloric, isonitrogenous standard enteral formula in critically ill patients receiving insulin treatment for blood glucose management.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
28
Continuous (24h) application according to a standardized enteral feeding protocol via nasogastric tube or percutaneous endoscopic gastrostomy (PEG); pump-assisted application (Charriére (CH) \> 8), duration according to patient's tolerance and requirements for a maximum of 5 days. Dosage: 21 - 24 kcal/kg body weight/day (corresponding to 14 to 16 ml/kg body weight/day).
Continuous (24h) application according to a standardized enteral feeding protocol via nasogastric tube or percutaneous endoscopic gastrostomy (PEG); pump-assisted application (Charriére (CH) \> 8), duration according to patient's tolerance and requirements for a maximum of 5 days. Dosage: 21 - 24 kcal/kg body weight/day (corresponding to 14 to 16 ml/kg body weight/day).
Universitätsklinikum Innsbruck
Innsbruck, Austria
Blood glucose variability (within patient standard deviation of blood glucose values per day)
Time frame: At Day 3 of intervention or the day prior to switch from intravenous to subcutaneous insulin administration, whichever comes first
Glucose variability
Time frame: Days 2, 4 and 5 of intervention
Time to switch from intravenous to subcutaneous insulin administration
Time frame: Days 1-6, daily
Insulin requirements in IU per day
Time frame: Days 1 - 6, daily
Blood glucose levels
Time frame: Days 1 - 6, daily
HbA1c
Time frame: Days 1, 6, 28
Difference between target and given enteral nutrition (Compliance)
Time frame: Days 2-6, daily
Cerebral and subcutaneous microdialysis: glucose
Time frame: Days 1 - 6, daily
Cerebral and subcutaneous microdialysis: lactate/pyruvate ratio
Time frame: Days 1 - 6, daily
Hospital mortality
Time frame: Day 28
ICU mortality
Time frame: Day 28
ICU length of stay
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Time frame: Day 28
Days of mechanical ventilation
Time frame: Day 28
Non-gastrointestinal complications (AEs) to enteral nutrition and application
Time frame: Days 2-6, daily
Gastro-intestinal intolerance (AEs, complications)
Time frame: Days 2-6, daily