Phase 2
N=74
Glucose Regulation in Acute Stroke Patients (GRASP) Study
Stroke · Hyperglycemia
Bottom Line
View on ClinicalTrials.gov: NCT00282867 ↗Enrolled (actual)
74
Serious AEs
—
Results posted
Aug 2009
Primary outcome: Primary: Hypoglycemic Events — 7; 1; 1 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- IV glucose insulin and potassium, GIK (Drug); standard care (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Virginia
- Primary completion
- Feb 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hypoglycemic Events |
7; 1; 1 | — |
| SECONDARY Favorable 3 Month Modified Rankin |
42; 25; 33 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT00282867). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.