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

Fresenius Kabi

Status: Terminated

Conditions: Aneurysmal Subarachnoid Hemorrhage

Treatments: Other: Fresubin HP Energy Fibre (1.5 kcal); Other: Diben 1.5 kcal HP

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02503527

DBHP-001-CEN

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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28 participants in 2 patient groups

Diben 1.5 kcal HP

Other group

Description:

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

Treatment:

Other: Diben 1.5 kcal HP

Fresubin HP Energy Fibre (1.5 kcal)

Other group

Description:

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

Treatment:

Other: Fresubin HP Energy Fibre (1.5 kcal)