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TerminatedNCT02503527Updated Mar 31, 2022

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

An interventional study of Diben 1.5 kcal HP and Fresubin HP Energy Fibre (1.5 kcal) in Aneurysmal Subarachnoid Hemorrhage, sponsored by Fresenius Kabi. Terminated at 1 site in Austria. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-03-31.

Sponsored by Fresenius Kabi · Not applicable, Interventional, and Supportive care

Why this study was terminated
Low Recruitment rate
Phase
Not applicable
Study type
Interventional
Enrollment
28
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Aneurysmal Subarachnoid Hemorrhage

Keywords

  • Enteral nutrition
  • Tube feeding
  • Diet, carbohydrate-restricted
  • Diabetes
  • Aneurysmal Subarachnoid Hemorrhage
  • Blood glucose
  • Insulin
03

In context

Subarachnoid Hemorrhage

509 studies on the registry are indexed under Subarachnoid Hemorrhage; 124 are open to participants now.

This study's enrollment of 28 is below the median of 52 across 263 interventional studies indexed under Subarachnoid Hemorrhage.

Browse Subarachnoid Hemorrhage studies →

Lead sponsor

Fresenius Kabi is the lead sponsor of 51 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
28 participants (actual)

Study arms

  • 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

  • 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)

Interventions

  • OtherDiben 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).

  • OtherFresubin 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).

06

What researchers measure

Primary outcomes

  1. Blood glucose variability (within patient standard deviation of blood glucose values per day)

    Time frame: At Day 3 of intervention or the day prior to switch from intravenous to subcutaneous insulin administration, whichever comes first

Secondary outcomes

  1. Glucose variability

    Time frame: Days 2, 4 and 5 of intervention

  2. Time to switch from intravenous to subcutaneous insulin administration

    Time frame: Days 1-6, daily

  3. Insulin requirements in IU per day

    Time frame: Days 1 - 6, daily

  4. Blood glucose levels

    Time frame: Days 1 - 6, daily

  5. HbA1c

    Time frame: Days 1, 6, 28

  6. Difference between target and given enteral nutrition (Compliance)

    Time frame: Days 2-6, daily

  7. Cerebral and subcutaneous microdialysis: glucose

    Time frame: Days 1 - 6, daily

  8. Cerebral and subcutaneous microdialysis: lactate/pyruvate ratio

    Time frame: Days 1 - 6, daily

  9. Hospital mortality

    Time frame: Day 28

  10. ICU mortality

    Time frame: Day 28

  11. ICU length of stay

    Time frame: Day 28

  12. Days of mechanical ventilation

    Time frame: Day 28

  13. Non-gastrointestinal complications (AEs) to enteral nutrition and application

    Time frame: Days 2-6, daily

  14. Gastro-intestinal intolerance (AEs, complications)

    Time frame: Days 2-6, daily

07

Study locations

1 site
  • Universitätsklinikum Innsbruck
    Innsbruck, 6020, Austria
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 31, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02503527
Lead sponsor
Fresenius Kabi
Collaborators
OE Clinical Trial Center (KKS) Universität Innsbruck, International Medical Research - Partner GmbH, dsh statistical services GmbH
Responsible party
Sponsor
First posted
Jul 21, 2015
Start date
Aug 2015
Primary completion
Aug 2018
Completion
Sep 2018
Last update
Mar 31, 2022

Study contacts

Ronny Beer, PD Dr. med.
principal investigator · Medical University of Innsbruck, Department of Neurology, Neurocritical Care Unit

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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