Clinical trial NCT02503527: Efficacy and Safety Study of a Low-carbohydrate Tube Feed in Critically Ill Patients Under Insulin Therapy
Official title: Effects of a Diabetes-specific Tube Feed on Glycemic Variability in Critically Ill Patients During Insulin Blood Glucose Management
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Aneurysmal Subarachnoid Hemorrhage
Keywords: Enteral nutrition
Tube feeding
Diet, carbohydrate-restricted
Diabetes
Aneurysmal Subarachnoid Hemorrhage
Blood glucose
Insulin
Lead sponsor: Fresenius Kabi
Sponsor class: INDUSTRY
Collaborators: name: OE Clinical Trial Center (KKS) Universität Innsbruck
name: International Medical Research - Partner GmbH
name: dsh statistical services GmbH
First posted: 2015-07-21
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Blood glucose variability (within patient standard deviation of blood glucose values per day)
timeFrame: At Day 3 of intervention or the day prior to switch from intravenous to subcutaneous insulin administration, whichever comes first
Secondary outcomes:
measure: Glucose variability
timeFrame: Days 2, 4 and 5 of intervention
measure: Time to switch from intravenous to subcutaneous insulin administration
timeFrame: Days 1-6, daily
measure: Insulin requirements in IU per day
timeFrame: Days 1 - 6, daily
measure: Blood glucose levels
timeFrame: Days 1 - 6, daily
measure: HbA1c
timeFrame: Days 1, 6, 28
measure: Difference between target and given enteral nutrition (Compliance)
timeFrame: Days 2-6, daily
measure: Cerebral and subcutaneous microdialysis: glucose
timeFrame: Days 1 - 6, daily
measure: Cerebral and subcutaneous microdialysis: lactate/pyruvate ratio
timeFrame: Days 1 - 6, daily
measure: Hospital mortality
timeFrame: Day 28
measure: ICU mortality
timeFrame: Day 28
measure: ICU length of stay
timeFrame: Day 28
measure: Days of mechanical ventilation
timeFrame: Day 28
measure: Non-gastrointestinal complications (AEs) to enteral nutrition and application
timeFrame: Days 2-6, daily
measure: Gastro-intestinal intolerance (AEs, complications)
timeFrame: Days 2-6, daily
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Universitätsklinikum Innsbruck
Study officials:
affiliation: Medical University of Innsbruck, Department of Neurology, Neurocritical Care Unit
name: Ronny Beer, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: