GRASP
Glucose Regulation in Acute Stroke Patients Trial
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Status:
Trial is complete. Manuscript is in revision.
Purpose:
To assess the feasibility and safety of glucose, insulin, potassium infusion in acute ischemic stroke patients.
Interventions:
Insulin infusion (GIK)
Recent data suggest that glucose-insulin-potassium infusion (GIK) in acute myocardial infarction results in an improved survival of patients, especially in patients undergoing reperfusion therapy.
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Location(s):
Georgia, Virginia.
Year Started:
2005
Year Finished:
2007
Year Presented:
2007
Design:
Multicenter, randomized, controlled trial with 3 treatment arms.
Inclusion Criteria
Adult acute ischemic stroke patients with hyperglycemia (glucose >110 mg/dL) within 24 hours of stroke symptom onset who can start study therapy within 2 hours of identified eligibility.
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.
Patient Involvement:
Patients are randomized to tight glucose control (target 70 – 110 mg/dL), loose glucose control (70 – 200 mg/dL), or usual care. Enrollment will be stratified by baseline glucose and predicted probability of outcome. Subjects in the tight and loose control groups will receive insulin infusions titrated to the assigned target glucose level. Glucose and potassium will be given at a continuous rate and meal insulin will be provided with meals. The control group will receive usual care. All subjects will receive diabetic education and nutrition counseling. A subgroup of subjects will receive continuous glucose monitoring with subcutaneous monitors for 3 days.
Primary Outcome:
The primary safety outcome is the rate of hypoglycemic events (glucose <55mg/dL). The primary feasibility outcome is the frequency of subjects in target range within 24 hours of treatment initiation.
Secondary Outcome:
NIH Stroke Scale, Barthel Index, Modified Rankin Scale, Glasgow Outcome Scale and the Stroke Impact Scale at 3 months.
Results:
A total of 73/74 (99%) of subjects had 3 month outcomes for analysis. The mean age was 67 years; 32% were black; 60% diabetic and 36% received r-tPA. The median NIHSS was 8, median glucose during treatment for loose control was 151 mg/dL and for tight control was 111 mg/dL. Excellent outcome by mRankin (0,1) occurred in 33% of usual care, 26% of loose control and 39% of tight control patients. After adjustment for predicted probability of outcome and glucose level, tight control had a favorable odds ratio of 1.36 and loose control did not at 0.73. An adjusted analysis of a predetermined subgroup; NIHSS 3–22 and glucose of over 150 mg/dL, demonstrated a favorable odds ratio for tight control of 2.6 and but not for loose control at 0.5. None of these
relationships reached statistical significance. The analysis of the devastating outcomes (mRankin 4, 5 and 6) also did not reach statistical significance but consistently suggested point estimates in favor of tight control over loose control in adjusted analyses. No statistical differences were found in any comparisons of the 3 groups in this pilot trial. The tight control group consistently had more favorable outcomes than the loose control group in adjusted and unadjusted analyses. An analysis of the predetermined subgroup of patient with NIHSS scores 3–22 and enrollment glucose over 150 mg/dL also provided valuable information on this subpopulation and supported the selection of the tight control protocol for future trials.
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Source of Information:
Presented at the 2006 International Stroke Conference [February 2006].
Correspondence with trial investigator.
Presented at the 2007 International Stroke Conference [February 2007].
Presented at the 2008 International Stroke Conference [February 2008].
Presented at the 2008 World Stroke Congress (Oct 2008).
Presented at the 2009 International Stroke Conference (Feb 2009).
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Web Links and Publications:
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This information last updated on: 10/19/2009
Reviewed on: 07/01/2009.
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