Aneurysmal Subarachnoid Hemorrhage
Conditions
Keywords
Enteral nutrition, Tube feeding, Diet, carbohydrate-restricted, Diabetes, Aneurysmal Subarachnoid Hemorrhage, Blood glucose, Insulin
Brief summary
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.
Interventions
OTHERDiben 1.5 kcal HP
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).
OTHERFresubin HP Energy Fibre (1.5 kcal)
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).
Sponsors
OE Clinical Trial Center (KKS) Universität Innsbruck
International Medical Research - Partner GmbH
dsh statistical services GmbH
Fresenius Kabi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients with spontaneous aneurysmal subarachnoid hemorrhage (SAH) defined according to Hunt and Hess scale grade HH5 * Requiring mechanical ventilation in the ICU at the time of enrolment * Enteral nutrition (EN) in the ICU at time of enrolment * If enrolment on day 3 of ICU stay, EN equal to or larger than 80% of total calories in case of supplementary parenteral nutrition (PN) with anticipated 100% EN as of day 4 to 8 of ICU stay * If enrolment on day 4 of ICU stay, 100% EN planned for at least 5 days from the time of enrolment * Patients expected to stay in the ICU for at least 5 days following enrolment * Age 18 - 75 years * Glycemic control with intravenous insulin therapy to maintain a target glucose range between 110 mg/dL and 150 mg/dL (6.1 and 8.3 mmol/l) * Informed consent according to local regulations for decisionally impaired subjects
Exclusion criteria
* Patients with septic shock at time of enrolment * Participation in a clinical trial with any investigational product within 4 weeks before study * Patients requiring a fibre free diet * Total or supplementary parenteral nutrition (\> 20% of total calories) * Known or suspected intolerance or allergy to any component of the study product(s), e.g. galactosemia * Gastrectomy * Postpyloric nutrition * Any clinical condition not allowing enteral nutrition (e.g. emesis, severe reflux, severe diarrhea) * Known severe heart failure (NYHA class 4) * Liver insufficiency / failure (male: ALAT \> 150 U/l; female: ALAT \> 120 U/l) * Acute kidney failure (blood creatinine \> 2.5 mg/dl) * Body Mass Index \< 18 or \> 35 kg/m² * Known or suspicion of drug abuse * Pregnant or breast feeding women * Patients with diabetes mellitus type I Exclusion After Enrolment (Withdrawal of Subjects) * Start of PN with more than 20% of total given energy amount/ day * Insulin infusion stopped unexpectedly for \> 12h for non-nutritional reasons * Discharge from ICU * Intolerable AEs * Major protocol violation * Withdrawal of informed consent * Discontinuation of study treatment for other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood glucose variability (within patient standard deviation of blood glucose values per day) | At Day 3 of intervention or the day prior to switch from intravenous to subcutaneous insulin administration, whichever comes first |
Secondary
| Measure | Time frame |
|---|---|
| Time to switch from intravenous to subcutaneous insulin administration | Days 1-6, daily |
| Insulin requirements in IU per day | Days 1 - 6, daily |
| Blood glucose levels | Days 1 - 6, daily |
| HbA1c | Days 1, 6, 28 |
| Difference between target and given enteral nutrition (Compliance) | Days 2-6, daily |
| Cerebral and subcutaneous microdialysis: glucose | Days 1 - 6, daily |
| Glucose variability | Days 2, 4 and 5 of intervention |
| Hospital mortality | Day 28 |
| ICU mortality | Day 28 |
| ICU length of stay | Day 28 |
| Days of mechanical ventilation | Day 28 |
| Non-gastrointestinal complications (AEs) to enteral nutrition and application | Days 2-6, daily |
| Gastro-intestinal intolerance (AEs, complications) | Days 2-6, daily |
| Cerebral and subcutaneous microdialysis: lactate/pyruvate ratio | Days 1 - 6, daily |
Countries
Austria
Outcome results
None listed