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

Not Applicable

Terminated

• Conditions: Aneurysmal Subarachnoid Hemorrhage
• Interventions: Other: Fresubin HP Energy Fibre (1.5 kcal); Other: Diben 1.5 kcal HP

• Registration Number: NCT02503527
• Lead Sponsor: Fresenius Kabi

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-07-10
• Study First Submitted QC: 2015-07-17
• Study First Posted: 2015-07-21
• Study Start: 2015-08
• Primary Completion: 2018-08
• Study Completion: 2018-09
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-15
• Last Update Posted: 2022-03-31

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fresubin HP Energy Fibre (1.5 kcal)	Fresubin HP Energy Fibre (1.5 kcal)	Fresubin HP Energy Fibre (1.5 kcal), Food for Special Medical Purposes (standard tube feed)
Diben 1.5 kcal HP	Diben 1.5 kcal HP	Diben 1.5 kcal HP, Food for Special Medical Purposes (diabetes-specific tube feed)

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
ICU mortality	Day 28
ICU length of stay	Day 28
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
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

Trial Locations

Locations (1)

Universitätsklinikum Innsbruck; 🇦🇹 Innsbruck, Austria