Glucose Regulation in Acute Stroke Patients (GRASP) trial: a randomized pilot trial

Abstract

Background and purpose: Hyperglycemia is associated with worse outcome in patients with acute stroke.

Methods: We conducted a prospective, randomized, multicenter, 3-arm trial (tight control [target 70 to 110 mg/dL], loose control [target 70 to 200 mg/dL], and control usual care [70 to 300 mg/dL]) to assess the feasibility and safety of 2 insulin infusion protocol targets in patients with acute ischemic stroke. The planned sample was 72 subjects.

Results: A total of 74 subjects were enrolled. Seventy-two (97%) had data available for the primary analyses and 73 (99%) had 3-month clinical outcome data. Median age was 67 years, median National Institutes of Health Stroke Scale score was 8, median glucose was 163 mg/dL, and median time to randomization was 10.7 hours. Fifty-nine percent of patients were diabetic, 35% received thrombolysis, and 14% of subjects died within 3 months. The loose control and usual care groups had median glucose concentrations of 151 mg/dL. The tight control group had a median glucose concentration of 111 mg/dL. The loose control group spent 90% of the first 24 hours in target and the tight group 44% of time in target. There was only one symptomatic patient with hypoglycemia in the loose control group (4%) and zero in the tight control group. The overall rates of hypoglycemia (<55 mg/dL) were 4% in control, 4% in loose, and 30% in tight. Exploratory efficacy analysis was conducted.

Conclusions: Insulin infusion for patients with acute ischemic stroke is feasible and safe using the insulin infusion protocol in the Glucose Regulation in Acute Stroke Patients (GRASP) trial. Exploratory efficacy analysis supports further comparative study.

Conflict of interest statement

The authors report no conflicts of interest to report related to this work.

Figures

Figure 1

The diagram demonstrates the CONSORT style patient enrollment flow diagram

Figure 2

Estimated median glucose concentrations for each of the three treatment groups over the first 24 hours are shown in Figure 2a. The curves were fit using quantile regression and 4-knot restricted cubic splines. The data points for figure 2a are shown in 2b.

Figure 2

Estimated median glucose concentrations for each of the three treatment groups over the first 24 hours are shown in Figure 2a. The curves were fit using quantile regression and 4-knot restricted cubic splines. The data points for figure 2a are shown in 2b.

Figure 3

Unadjusted and adjusted odds of favorable outcome by mRankin (0,1) at 3 months in the loose control group compared to usual care and the tight control group compared to usual care. The null line (0) reflects the usual care group. THIS is the Treatment of Hyperglycemia in Ischemic Stroke Trial and the adjusted analysis for THIS included the subgroup that resembles the THIS Trial patients.