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

NCT ID: NCT02503527

Last Updated: 2022-03-31

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2018-09-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Diben 1.5 kcal HP

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

Group Type: OTHER

Diben 1.5 kcal HP

Intervention Type: 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)

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

Group Type: OTHER

Fresubin HP Energy Fibre (1.5 kcal)

Intervention Type: 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).

Interventions

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).

Intervention Type: 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).

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

OE Clinical Trial Center (KKS) Universität Innsbruck

UNKNOWN

Sponsor Role: collaborator

International Medical Research - Partner GmbH

OTHER

Sponsor Role: collaborator

dsh statistical services GmbH

UNKNOWN

Sponsor Role: collaborator

Fresenius Kabi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ronny Beer, PD Dr. med.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Universitätsklinikum Innsbruck

Innsbruck, , Austria

Countries

Austria

Other Identifiers

DBHP-001-CEN

Identifier Type: -

Identifier Source: org_study_id