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

NCT02503527 | Terminated

• 1 other identifier: DBHP-001-CEN
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Aneurysmal Subarachnoid Hemorrhage

Keywords

Enteral nutrition; Tube feeding; Diet, carbohydrate-restricted; Diabetes; Aneurysmal Subarachnoid Hemorrhage; Blood glucose; Insulin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• 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

Study Arms (2)

Diben 1.5 kcal HP

OTHER

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

Other: Diben 1.5 kcal HP

Fresubin HP Energy Fibre (1.5 kcal)

OTHER

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

Other: Fresubin HP Energy Fibre (1.5 kcal)

Interventions

Diben 1.5 kcal HP OTHER

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).

Diben 1.5 kcal HP

Fresubin HP Energy Fibre (1.5 kcal) OTHER

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).

Fresubin HP Energy Fibre (1.5 kcal)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fresenius Kabi: lead
• OE Clinical Trial Center (KKS) Universität Innsbruck: collaborator
• International Medical Research - Partner GmbH: collaborator
• dsh statistical services GmbH: collaborator

Study Sites (1)

Universitätsklinikum Innsbruck

Innsbruck, 6020, Austria

Location

MeSH Terms

Conditions

Subarachnoid Hemorrhage; Diabetes Mellitus; Insulin Resistance

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Study Officials

• Ronny Beer, PD Dr. med.

  Medical University of Innsbruck, Department of Neurology, Neurocritical Care Unit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2015
• First Posted: July 21, 2015
• Study Start: August 1, 2015
• Primary Completion: August 1, 2018
• Study Completion: September 1, 2018
• Last Updated: March 31, 2022

Record last verified: 2022-03

Locations

AU (1)