Subarachnoid HemorrhagePhase 4ANUS1014NCT01463878
Enteral Nutrition and Glycemic Variability Neurological Intensive Care Unit Study
A Phase 4 study testing Glycerna in people with Subarachnoid Hemorrhage and Intracranial Hemorrhage, run by Eastern Virginia Medical School at 1 site in United States.
Trial summary
Primary Objective: To determine the effects of a diabetes specific enteral formula compared to a standard formula supplemented with protein (isocaloric and isonitrogenous) on the mean blood glucose and glycemic variability in a homogenous group of critically ill patients in a neurological ICU. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Subarachnoid Hemorrhage, Intracranial Hemorrhage, Ischemic Strokes
- What is being tested?
- Glycerna
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Jun 2012
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged between 18 and 89 years old
- Patients with critical illness including ischemic or hemorrhagic stroke, epidural/subdural bleeds and subarachnoid hemorrhage
- Patients who are expected to stay in the ICU for at least 5 days
- Hyperglycemia is not an inclusion criteria
Who cannot join
- Patients who have received or will be treated with systemic corticosteroids.
- Patients who will be receiving high doses of propofol (>40 cc/hr)
- Patients with type 1 Diabetes
- Patients with sepsis or acute trauma
- Patients with an expected stay in the ICU of less than 4 days
- Patients who are unable to receive enteral nutrition or who have medical conditions precluding nutrition by the enteral route including allergies to formula components
Show all 10Show fewer
- Pregnant and lactating patients
- Patients with prior history of gastroparesis
- Patients with acute kidney failure (creatinine > 2.5mg/dl)
- Patients with acute liver failure (bilirubin > 2.0 mg/dl)
Trial locations and contacts
1 site in 1 country.
United States1 site
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507
About this study
Official title: Enteral Nutrition and Glycemic Variability NICU Study
Primary Objective:
To determine the effects of a diabetes specific enteral formula compared to a standard formula supplemented with protein (isocaloric and isonitrogenous) on the mean blood glucose and glycemic variability in a homogenous group of critically ill patients in a neurological ICU. Blood glucose will be recorded every minute using a continuous blood glucose monitor. The primary end points will be the difference between the mean blood glucose levels and the glucose variability between the control and intervention groups for the time period that the patient is in the ICU and receiving tube feeds and for up to a maximum of 14 days.
Read more
Secondary Objectives:
To determine the effects of the diabetes specific versus standard tube feeds on the change in muscle thickness and volume measured by 2-dimensional ultrasound imaging during the patients ICU stay.
- Being tested
- Glycerna, Jevity - Control Diet
- Keywords
- glycemic control, glycemic variability, mean blood glucose level
- Medical subject headings
- Subarachnoid Hemorrhage, Intracranial Hemorrhages, Ischemic Stroke, Hematoma, Subdural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlycernaDietary supplement
Diabetes specific formula
Jevity - Control DietDietary supplement
Control Diet
| Study group | Role | What they receive |
|---|---|---|
| Glycerna | Experimental | Diabetic specific formula. The volume /rate of glycerna will be determined by the dietician according to standard formula. Receives: Dietary Supplement: Glycerna |
| Control - Jevity | Active comparator | The control arm of the study. Patients to receive Jevity. The volume /rate of Jevity will be determined by the dietician according to standard formula. Receives: Dietary Supplement: Jevity - Control Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic Variability
The patients blood glucose levels will be monitored with a continuous blood glucose monitor which records the calibrated blood glucose level every minute. The mean blood glucose over the patients entire ICU stay (up to 14 days) as well as the mathematical variation (fluctuation) in blood glucose levels will be calculated. The degree of glycemic variation will be assessed by a number of mathematical formula, including mean amplitude of glycemic excursions (MAGE). These parameters will be compared between the control and intervention groups.
Measured: Entire ICU stay. Up to 14 days in the ICU (average about 7 days)
Secondary outcomes (1)
Quadriceps Muscle Volume
The quadriceps muscle volume will be estimated by 2-dimensional ultrasound imaging at enrollment and at the end of the study period (when the patient is being transferred from the ICU or no longer receiving tube feeds). The change in muscle mass during the ICU stay will be compared between the control and intervention groups.
Measured: First versus last measurment in ICU. Up to 14 days (average 7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionJun 2012
- Study completionJun 2012
Why it stopped: Unlikely to show statistical significance and slow recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eastern Virginia Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul Marik, Eastern Virginia Medical School
- Investigators
- Paul e Marik, MD, Principal investigator, EVMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01463878
- Sponsor's protocol ID
- ANUS1014
- Acronym
- ANUS1014
- Status last verified
- Oct 2012
- First submitted
- 24 Oct 2011
- Last updated
- 5 Oct 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enteral Nutrition and Glycemic Variability NICU Study
- ClinicalTrials.gov ID
- NCT01463878
- Acronym / sponsor ID
- ANUS1014 / ANUS1014
- Keywords
- glycemic control, glycemic variability, mean blood glucose level
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unlikely to show statistical significance and slow recruitment.
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Eastern Virginia Medical SchoolUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 2 Nov 2011 (estimated)
- Results
- Posted 28 Sep 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Objective:
To determine the effects of a diabetes specific enteral formula compared to a standard formula supplemented with protein (isocaloric and isonitrogenous) on the mean blood glucose and glycemic variability in a homogenous group of critically ill patients in a neurological ICU. Blood glucose will be recorded every minute using a continuous blood glucose monitor. The primary end points will be the difference between the mean blood glucose levels and the glucose variability between the control and intervention groups for the time period that the patient is in the ICU and receiving tube feeds and for up to a maximum of 14 days.
Secondary Objectives:
To determine the effects of the diabetes specific versus standard tube feeds on the change in muscle thickness and volume measured by 2-dimensional ultrasound imaging during the patients ICU stay.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glycerna | Experimental | Dietary Supplement: GlycernaDiabetic specific formula. The volume /rate of glycerna will be determined by the dietician according to standard formula. |
| Control - Jevity | Active comparator | Dietary Supplement: Jevity - Control DietThe control arm of the study. Patients to receive Jevity. The volume /rate of Jevity will be determined by the dietician according to standard formula. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged between 18 and 89 years old
- Patients with critical illness including ischemic or hemorrhagic stroke, epidural/subdural bleeds and subarachnoid hemorrhage
- Patients who are expected to stay in the ICU for at least 5 days
- Hyperglycemia is not an inclusion criteria
Key exclusion criteria (10 listed)
- Patients who have received or will be treated with systemic corticosteroids.
- Patients who will be receiving high doses of propofol (>40 cc/hr)
- Patients with type 1 Diabetes
- Patients with sepsis or acute trauma
- Patients with an expected stay in the ICU of less than 4 days
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 |
|---|---|---|
| GlycernaDiabetes specific formula | Dietary supplement | Glycerna |
| Jevity - Control DietControl Diet | Dietary supplement | Control - Jevity |
Primary outcome
Glycemic Variability
Time frame: Entire ICU stay. Up to 14 days in the ICU (average about 7 days)
The patients blood glucose levels will be monitored with a continuous blood glucose monitor which records the calibrated blood glucose level every minute. The mean blood glucose over the patients entire ICU stay (up to 14 days) as well as the mathematical variation (fluctuation) in blood glucose levels will be calculated. The degree of glycemic variation will be assessed by a number of mathematical formula, including mean amplitude of glycemic excursions (MAGE). These parameters will be compared between the control and intervention groups.
1 secondary outcome
Quadriceps Muscle Volume
Time frame: First versus last measurment in ICU. Up to 14 days (average 7 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Paul e Marik, MD principal investigator
EVMS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Glycerna in people with Subarachnoid Hemorrhage and Intracranial Hemorrhage, run by Eastern Virginia Medical School at 1 site in United States.
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 4 inclusion and 10 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 5 Oct 2012. 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 United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Sep 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Glycemic Variability (time frame: Entire ICU stay. Up to 14 days in the ICU (average about 7 days)). 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 5 Oct 2012.