Aneurysmal Subarachnoid HemorrhageNCT02503527
Efficacy and Safety Study of a Low-carbohydrate Tube Feed in Critically Ill Patients Under Insulin Therapy
A study testing Diben 1.5 kcal HP and Fresubin HP Energy Fibre (1.5 kcal) in people with Aneurysmal Subarachnoid Hemorrhage, run by Fresenius Kabi at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Aneurysmal Subarachnoid Hemorrhage
- What is being tested?
- Diben 1.5 kcal HP and Fresubin HP Energy Fibre (1.5 kcal)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteAustria
- Study dates
- Aug 2015to Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Aneurysmal Subarachnoid Hemorrhage
- Being tested
- Diben 1.5 kcal HP, Fresubin HP Energy Fibre (1.5 kcal)
- Keywords
- Enteral nutrition, Tube feeding, Diet, carbohydrate-restricted, Diabetes, Aneurysmal Subarachnoid Hemorrhage, Blood glucose, Insulin
- Medical subject headings
- Subarachnoid Hemorrhage, Diabetes Mellitus, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diben 1.5 kcal HPOther
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)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).
| Study group | Role | What they receive |
|---|---|---|
| Diben 1.5 kcal HP | Other | Diben 1.5 kcal HP, Food for Special Medical Purposes (diabetes-specific tube feed) Receives: Other: Diben 1.5 kcal HP |
| Fresubin HP Energy Fibre (1.5 kcal) | Other | Fresubin HP Energy Fibre (1.5 kcal), Food for Special Medical Purposes (standard tube feed) Receives: Other: Fresubin HP Energy Fibre (1.5 kcal) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood glucose variability (within patient standard deviation of blood glucose values per day)
Measured: At Day 3 of intervention or the day prior to switch from intravenous to subcutaneous insulin administration, whichever comes first
Secondary outcomes (14)
Glucose variability
Measured: Days 2, 4 and 5 of intervention
Time to switch from intravenous to subcutaneous insulin administration
Measured: Days 1-6, daily
Insulin requirements in IU per day
Measured: Days 1 - 6, daily
Blood glucose levels
Measured: Days 1 - 6, daily
HbA1c
Measured: Days 1, 6, 28
Difference between target and given enteral nutrition (Compliance)
Measured: Days 2-6, daily
Cerebral and subcutaneous microdialysis: glucose
Measured: Days 1 - 6, daily
Cerebral and subcutaneous microdialysis: lactate/pyruvate ratio
Measured: Days 1 - 6, daily
Hospital mortality
Measured: Day 28
ICU mortality
Measured: Day 28
ICU length of stay
Measured: Day 28
Days of mechanical ventilation
Measured: Day 28
Non-gastrointestinal complications (AEs) to enteral nutrition and application
Measured: Days 2-6, daily
Gastro-intestinal intolerance (AEs, complications)
Measured: Days 2-6, daily
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2015 (estimated)
- Study startAug 2015
- Primary completionAug 2018
- Study completionSep 2018
Why it stopped: Low Recruitment rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aneurysmal Subarachnoid HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fresenius Kabi
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medical University Innsbruck, International Medical Research - Partner GmbH, dsh statistical services GmbH
- Responsible party
- Sponsor
- Investigators
- Ronny Beer, PD Dr. med., Principal investigator, Medical University of Innsbruck, Department of Neurology, Neurocritical Care Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02503527
- Sponsor's protocol ID
- DBHP-001-CEN
- Status last verified
- Mar 2022
- First submitted
- 10 Jul 2015
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Diabetes-specific Tube Feed on Glycemic Variability in Critically Ill Patients During Insulin Blood Glucose Management
- ClinicalTrials.gov ID
- NCT02503527
- Acronym / sponsor ID
- DBHP-001-CEN
- Conditions
- Aneurysmal Subarachnoid Hemorrhage
- Keywords
- Enteral nutrition, Tube feeding, Diet, carbohydrate-restricted, Diabetes, Aneurysmal Subarachnoid Hemorrhage, Blood glucose, Insulin
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low Recruitment rate
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Fresenius KabiIndustry (pharma, biotech, devices)
- Collaborators
- Medical University Innsbruck, International Medical Research - Partner GmbH, dsh statistical services GmbH
- Study start
- Aug 2015
- Primary completion
- Aug 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 21 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diben 1.5 kcal HP | Other | Other: Diben 1.5 kcal HPDiben 1.5 kcal HP, Food for Special Medical Purposes (diabetes-specific tube feed) |
| Fresubin HP Energy Fibre (1.5 kcal) | Other | Other: Fresubin HP Energy Fibre (1.5 kcal)Fresubin HP Energy Fibre (1.5 kcal), Food for Special Medical Purposes (standard tube feed) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
- Patients expected to stay in the ICU for at least 5 days following enrolment
- Age 18 - 75 years
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diben 1.5 kcal HPContinuous (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 | Diben 1.5 kcal HP |
| 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). | Other | Fresubin HP Energy Fibre (1.5 kcal) |
Primary outcome
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
14 secondary outcomes
Glucose variability
Time frame: Days 2, 4 and 5 of intervention
Time to switch from intravenous to subcutaneous insulin administration
Time frame: Days 1-6, daily
Insulin requirements in IU per day
Time frame: Days 1 - 6, daily
Blood glucose levels
Time frame: Days 1 - 6, daily
HbA1c
Time frame: Days 1, 6, 28
Difference between target and given enteral nutrition (Compliance)
Time frame: Days 2-6, daily
Cerebral and subcutaneous microdialysis: glucose
Time frame: Days 1 - 6, daily
Cerebral and subcutaneous microdialysis: lactate/pyruvate ratio
Time frame: Days 1 - 6, daily
Hospital mortality
Time frame: Day 28
ICU mortality
Time frame: Day 28
ICU length of stay
Time frame: Day 28
Days of mechanical ventilation
Time frame: Day 28
Non-gastrointestinal complications (AEs) to enteral nutrition and application
Time frame: Days 2-6, daily
Gastro-intestinal intolerance (AEs, complications)
Time frame: Days 2-6, daily
Results and safety
The study was stopped early (reason given: Low Recruitment rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronny Beer, PD Dr. med. principal investigator
Medical University of Innsbruck, Department of Neurology, Neurocritical Care Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diben 1.5 kcal HP and Fresubin HP Energy Fibre (1.5 kcal) in people with Aneurysmal Subarachnoid Hemorrhage, run by Fresenius Kabi at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Low Recruitment rate). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.