StrokePhase 2NCT00282867
Glucose Regulation in Acute Stroke Patients (GRASP) Study
A Phase 2 study testing IV glucose insulin and potassium, GIK in people with Stroke and Hyperglycemia, run by University of Virginia at 2 sites in United States.
Trial summary
The purpose of this study is to assess the feasibility, safety and preliminary efficacy of the use of insulin infusions as treatment for hyperglycemic acute ischemic stroke patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Hyperglycemia
- What is being tested?
- IV glucose insulin and potassium, GIK
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2006to Feb 2009
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older.
- Clinical diagnosis of ischemic stroke defined as acute neurological deficit occurring in one or more major vessels.
- Must arrive at hospital and be able to begin treatment within 2 hours of established eligibility and this must be within 24 hours of symptom onset. - - Patients unable to report symptom onset time or those awakening with symptoms must use the time last known to be well as the onset time.
- Admission plasma glucose of > 110 mg/dL.
Who cannot join
- Renal dysfunction as defined by a serum creatinine of >/=2.5 mg/dL at enrollment.
- Substantial pre-existing neurological or psychiatric illness that would confound neurological assessment.
- Patients who have received experimental therapy for the enrollment stroke.
- Pregnant females.
- Patients with other severe life threatening conditions that makes them unlikely to survive 90 days.
- Patients who are unable to follow the protocol or come back for 90-day followup.
- Patient has condition for which insulin infusion is the usual practice or the treating physician feels that there is an indication for insulin infusion.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Medical College of Georgia
Augusta, Georgia, 30912
University of Virginia
Charlottesville, Virginia, 22908
About this study
The purpose of this study is to assess the feasibility, safety and preliminary efficacy of the use of insulin infusions as treatment for hyperglycemic acute ischemic stroke patients.
Read the detailed description
Ischemic stroke is a common, devastating and costly disease. Half of acute stroke patients have elevated glucose levels upon admission to the hospital, and hyperglycemia is associated with poor outcome for post-stroke patients. It is unclear if treatment of hyperglycemia or glucose lowering improves outcome, however, in animal stroke models and other human conditions, aggressive glucose lowering is beneficial.
The goal of this multicenter trial is to determine if tight control of blood glucose is beneficial in hyperglycemic patients with acute ischemic stroke. In the trial, researchers will compare intravenous (IV) glucose insulin and potassium (GIK) therapy plus meal insulin to control therapy in 72 stroke patients.
Participants will be randomly assigned to one of three groups-(1) the control group with a target glucose level of <300mg/dL; (2) the tight control GIK plus meal insulin group with a target of <110mg/dL; or (3) the loose control GIK plus meal insulin group with a target of <200mg/dL-with all groups avoiding glucose levels of <70mg/dL.
The specific aims of this study are to collect preliminary data on the safety and feasibility of GIK for treatment of hyperglycemia in acute stroke patients, and to collect preliminary data comparing tight GIK therapy with loose GIK therapy and control therapy. Information learned in this study will compliment ongoing work and allow for maximum efficiency in the design of future treatment trials.
- Conditions
- Stroke, Hyperglycemia
- Being tested
- IV glucose insulin and potassium, GIK, standard care
- Keywords
- stroke, acute ischemic stroke, hyperglycemia, glucose, insulin, insulin and potassium therapy, GIK
- Medical subject headings
- Stroke, Hyperglycemia, Ischemic Stroke, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV glucose insulin and potassium, GIKDrug
The treatment intervention includes glucose, insulin, potassium infusion or standard therapy.
standard careOther
usual care
| Study group | Role | What they receive |
|---|---|---|
| tight control group | Active comparator | target glucose level 70-110 mg/dL Receives: Drug: IV glucose insulin and potassium, GIK |
| loose control group | Active comparator | target glucose level 70 - 200 mg/dL Receives: Drug: IV glucose insulin and potassium, GIK |
| usual care group | Active comparator | target level 70 - 300 mg/dL Receives: Other: standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypoglycemic Events
hypoglycemic events
Measured: up to 5 days
Secondary outcomes (1)
Favorable 3 Month Modified Rankin
3 month functional outcomes by modified Rankin (0 to 1) dichotomized as favorable versus not favorable outcome. Construct is functional handicap.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2006 (estimated)
- Study startMay 2006
- Primary completionFeb 2008
- Study completionFeb 2009
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 StrokeStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Investigators
- Karen Johnston, MD, Principal investigator, University of Virginia, Department of Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00282867
- Sponsor's protocol ID
- 11901
- Other IDs
- R01NS050192
- Status last verified
- Jul 2009
- First submitted
- 26 Jan 2006
- Last updated
- 21 Aug 2009
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glucose Regulation in Acute Stroke Patients (GRASP) Study
- ClinicalTrials.gov ID
- NCT00282867
- Acronym / sponsor ID
- 11901
- Conditions
- Stroke, Hyperglycemia
- Keywords
- stroke, acute ischemic stroke, hyperglycemia, glucose, insulin, insulin and potassium therapy, GIK
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- May 2006
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 27 Jan 2006 (estimated)
- Results
- Posted 21 Aug 2009
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 assess the feasibility, safety and preliminary efficacy of the use of insulin infusions as treatment for hyperglycemic acute ischemic stroke patients.
Detailed description
Ischemic stroke is a common, devastating and costly disease. Half of acute stroke patients have elevated glucose levels upon admission to the hospital, and hyperglycemia is associated with poor outcome for post-stroke patients. It is unclear if treatment of hyperglycemia or glucose lowering improves outcome, however, in animal stroke models and other human conditions, aggressive glucose lowering is beneficial.
The goal of this multicenter trial is to determine if tight control of blood glucose is beneficial in hyperglycemic patients with acute ischemic stroke. In the trial, researchers will compare intravenous (IV) glucose insulin and potassium (GIK) therapy plus meal insulin to control therapy in 72 stroke patients.
Participants will be randomly assigned to one of three groups-(1) the control group with a target glucose level of <300mg/dL; (2) the tight control GIK plus meal insulin group with a target of <110mg/dL; or (3) the loose control GIK plus meal insulin group with a target of <200mg/dL-with all groups avoiding glucose levels of <70mg/dL.
The specific aims of this study are to collect preliminary data on the safety and feasibility of GIK for treatment of hyperglycemia in acute stroke patients, and to collect preliminary data comparing tight GIK therapy with loose GIK therapy and control therapy. Information learned in this study will compliment ongoing work and allow for maximum efficiency in the design of future treatment trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| tight control group | Active comparator | Drug: IV glucose insulin and potassium, GIKtarget glucose level 70-110 mg/dL |
| loose control group | Active comparator | Drug: IV glucose insulin and potassium, GIKtarget glucose level 70 - 200 mg/dL |
| usual care group | Active comparator | Other: standard caretarget level 70 - 300 mg/dL |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years of age or older.
- Clinical diagnosis of ischemic stroke defined as acute neurological deficit occurring in one or more major vessels.
- Must arrive at hospital and be able to begin treatment within 2 hours of established eligibility and this must be within 24 hours of symptom onset. - - Patients unable to report symptom onset time or those awakening with symptoms must use the time last known to be well as the onset time.
- Admission plasma glucose of > 110 mg/dL.
Key exclusion criteria (7 listed)
- Renal dysfunction as defined by a serum creatinine of >/=2.5 mg/dL at enrollment.
- Substantial pre-existing neurological or psychiatric illness that would confound neurological assessment.
- Patients who have received experimental therapy for the enrollment stroke.
- Pregnant females.
- Patients with other severe life threatening conditions that makes them unlikely to survive 90 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 |
|---|---|---|
| IV glucose insulin and potassium, GIKThe treatment intervention includes glucose, insulin, potassium infusion or standard therapy. | Drug | loose control group, tight control group |
| standard careusual care | Other | usual care group |
Primary outcome
Hypoglycemic Events
Time frame: up to 5 days
hypoglycemic events
1 secondary outcome
Favorable 3 Month Modified Rankin
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2009.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Stroke
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Stroke and Systemic Embolism Prevention in Adult Participants With Atrial Fibrillation
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The Effects of an Augmented Reality-Based Mirror Therapy System in Patients With Stroke
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A Pivotal Study Evaluating Safety and Effectiveness of Adaptative Tip Catheter in Patients With Acute Ischemic Stroke
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Role of EEG in Differentiation Between Ischemic and Hemorrhagic Stroke
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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.
Karen Johnston, MD principal investigator
University of Virginia, Department of Neurology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IV glucose insulin and potassium, GIK in people with Stroke and Hyperglycemia, run by University of Virginia at 2 sites 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 7 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: finished, as of the sponsor's last update on 21 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 21 Aug 2009). 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?
Hypoglycemic Events (time frame: up to 5 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 21 Aug 2009.