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

March 15, 2022 updated by: Fresenius Kabi

Effects of a Diabetes-specific Tube Feed on Glycemic Variability in Critically Ill Patients During Insulin Blood Glucose Management

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
28

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Innsbruck, Austria, 6020
        • Universitätsklinikum Innsbruck

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
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).
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)
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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
At Day 3 of intervention or the day prior to switch from intravenous to subcutaneous insulin administration, whichever comes first

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Glucose variability
Time Frame: Days 2, 4 and 5 of intervention
Days 2, 4 and 5 of intervention
Time to switch from intravenous to subcutaneous insulin administration
Time Frame: Days 1-6, daily
Days 1-6, daily
Insulin requirements in IU per day
Time Frame: Days 1 - 6, daily
Days 1 - 6, daily
Blood glucose levels
Time Frame: Days 1 - 6, daily
Days 1 - 6, daily
HbA1c
Time Frame: Days 1, 6, 28
Days 1, 6, 28
Difference between target and given enteral nutrition (Compliance)
Time Frame: Days 2-6, daily
Days 2-6, daily
Cerebral and subcutaneous microdialysis: glucose
Time Frame: Days 1 - 6, daily
Days 1 - 6, daily
Cerebral and subcutaneous microdialysis: lactate/pyruvate ratio
Time Frame: Days 1 - 6, daily
Days 1 - 6, daily
Hospital mortality
Time Frame: Day 28
Day 28
ICU mortality
Time Frame: Day 28
Day 28
ICU length of stay
Time Frame: Day 28
Day 28
Days of mechanical ventilation
Time Frame: Day 28
Day 28
Non-gastrointestinal complications (AEs) to enteral nutrition and application
Time Frame: Days 2-6, daily
Days 2-6, daily
Gastro-intestinal intolerance (AEs, complications)
Time Frame: Days 2-6, daily
Days 2-6, daily

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fresenius Kabi

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
OE Clinical Trial Center (KKS) Universität Innsbruck
International Medical Research - Partner GmbH
dsh statistical services GmbH

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ronny Beer, PD Dr. med., Medical University of Innsbruck, Department of Neurology, Neurocritical Care Unit

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 10, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 17, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 21, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 31, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 15, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DBHP-001-CEN

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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