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

Sponsor

Fresenius Kabi (Industry)

Overall Status

Terminated

CT.gov ID

NCT02503527

Collaborator

OE Clinical Trial Center (KKS) Universität Innsbruck (Other), International Medical Research - Partner GmbH (Other), dsh statistical services GmbH (Other)

Enrollment

Location

Arms

Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Aneurysmal Subarachnoid Hemorrhage	Other: Diben 1.5 kcal HP Other: Fresubin HP Energy Fibre (1.5 kcal)	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

28 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Supportive Care

Official Title:

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

Study Start Date :

Aug 1, 2015

Actual Primary Completion Date :

Aug 1, 2018

Actual Study Completion Date :

Sep 1, 2018

Arms and Interventions

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

Arm

Intervention/Treatment

Other: Diben 1.5 kcal HP

Diben 1.5 kcal HP, Food for Special Medical Purposes (diabetes-specific tube feed)

Other: Diben 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).

Other: Fresubin HP Energy Fibre (1.5 kcal)

Fresubin HP Energy Fibre (1.5 kcal), Food for Special Medical Purposes (standard tube feed)

Other: Fresubin HP Energy Fibre (1.5 kcal)

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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