Efficacy and Safety Study of a Low-carbohydrate Tube Feed in Critically Ill Patients Under Insulin Therapy

Study Overview
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Brief Summary
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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.

Official Title
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Effects of a Diabetes-specific Tube Feed on Glycemic Variability in Critically Ill Patients During Insulin Blood Glucose Management

Conditions
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Aneurysmal Subarachnoid Hemorrhage

Intervention / Treatment
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* Other: Diben 1.5 kcal HP
* Other: Fresubin HP Energy Fibre (1.5 kcal)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Diben 1.5 kcal HP<br>Diben 1.5 kcal HP, Food for Special Medical Purposes (diabetes-specific tube feed) | Other: Diben 1.5 kcal HP<br>* 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).<br>|
| Other: Fresubin HP Energy Fibre (1.5 kcal)<br>Fresubin HP Energy Fibre (1.5 kcal), Food for Special Medical Purposes (standard tube feed) | Other: Fresubin HP Energy Fibre (1.5 kcal)<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose variability |  | Days 2, 4 and 5 of intervention | 
| 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 | 
| Cerebral and subcutaneous microdialysis: lactate/pyruvate ratio |  | Days 1 - 6, daily | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Enteral nutrition, Tube feeding, Diet, carbohydrate-restricted, Diabetes, Aneurysmal Subarachnoid Hemorrhage, Blood glucose, Insulin