NCT02503527TerminatedNot Applicable
Effects of a Diabetes-specific Tube Feed on Glycemic Variability in Critically Ill Patients During Insulin Blood Glucose Management
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Fresenius Kabi
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- Blood glucose variability (within patient standard deviation of blood glucose values per day)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Diben 1.5 kcal HP
Other
Diben 1.5 kcal HP, Food for Special Medical Purposes (diabetes-specific tube feed)
Intervention: Diben 1.5 kcal HP (Other)
Fresubin HP Energy Fibre (1.5 kcal)
Other
Fresubin HP Energy Fibre (1.5 kcal), Food for Special Medical Purposes (standard tube feed)
Intervention: Fresubin HP Energy Fibre (1.5 kcal) (Other)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- ICU mortality(Day 28)
- ICU length of stay(Day 28)
- 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)
- 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)
Investigators
Study Sites (1)
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