TY - JOUR
T1 - The Stroke Hyperglycemia Insulin Network Effort (SHINE) trial protocol
T2 - A randomized, blinded, efficacy trial of standard vs. intensive hyperglycemia management in acute stroke
AU - Bruno, Askiel
AU - Durkalski, Valerie L.
AU - Hall, Christiana E.
AU - Juneja, Rattan
AU - Barsan, William G.
AU - Janis, Scott
AU - Meurer, William J.
AU - Fansler, Amy
AU - Johnston, Karen C.
PY - 2014/2
Y1 - 2014/2
N2 - Rationale: Patients with acute ischemic stroke and hyperglycemia have worse outcomes than those without hyperglycemia. Intensive glucose control during acute stroke is feasible and can be accomplished safely but has not been fully assessed for efficacy. Aims: The Stroke Hyperglycemia Insulin Network Effort trial aims to determine the safety and efficacy of standard vs. intensive glucose control with insulin in hyperglycemic acute ischemic stroke patients. Design: This is a randomized, blinded, multicenter, phase III trial of approximately 1400 hyperglycemic patients who receive either standard sliding scale subcutaneous insulin (blood glucose range 80-179mg/dL, 4·44-9·93mmol/L) or continuous intravenous insulin (target blood glucose 80-130mg/dL, 4·44-7·21mmol/L) for up to 72h, starting within 12h of stroke symptom onset. The acute treatment phase is single blind (for the patients), but the final outcome assessment is double blind. The study is powered to detect a 7% absolute difference in favorable outcome at 90 days. Study outcomes: The primary outcome is a baseline severity adjusted 90-day modified Rankin Scale score, defined as 0, 0-1, or 0-2, if the baseline National Institutes of Health Stroke Scale score is 3-7, 8-14, or 15-22, respectively. The primary safety outcome is the rate of severe hypoglycemia (<40mg/dL, <2·22mmol/L). Discussion: This trial will provide important novel information about preferred management of acute ischemic stroke patients with hyperglycemia. It will determine the potential benefits and risks of intensive glucose control during acute stroke.
AB - Rationale: Patients with acute ischemic stroke and hyperglycemia have worse outcomes than those without hyperglycemia. Intensive glucose control during acute stroke is feasible and can be accomplished safely but has not been fully assessed for efficacy. Aims: The Stroke Hyperglycemia Insulin Network Effort trial aims to determine the safety and efficacy of standard vs. intensive glucose control with insulin in hyperglycemic acute ischemic stroke patients. Design: This is a randomized, blinded, multicenter, phase III trial of approximately 1400 hyperglycemic patients who receive either standard sliding scale subcutaneous insulin (blood glucose range 80-179mg/dL, 4·44-9·93mmol/L) or continuous intravenous insulin (target blood glucose 80-130mg/dL, 4·44-7·21mmol/L) for up to 72h, starting within 12h of stroke symptom onset. The acute treatment phase is single blind (for the patients), but the final outcome assessment is double blind. The study is powered to detect a 7% absolute difference in favorable outcome at 90 days. Study outcomes: The primary outcome is a baseline severity adjusted 90-day modified Rankin Scale score, defined as 0, 0-1, or 0-2, if the baseline National Institutes of Health Stroke Scale score is 3-7, 8-14, or 15-22, respectively. The primary safety outcome is the rate of severe hypoglycemia (<40mg/dL, <2·22mmol/L). Discussion: This trial will provide important novel information about preferred management of acute ischemic stroke patients with hyperglycemia. It will determine the potential benefits and risks of intensive glucose control during acute stroke.
KW - Acute ischemic stroke
KW - Cerebral infarction
KW - Clinical trial
KW - Hyperglycemia
KW - Protocols
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U2 - 10.1111/ijs.12045
DO - 10.1111/ijs.12045
M3 - Article
C2 - 23506245
AN - SCOPUS:84892697797
SN - 1747-4930
VL - 9
SP - 246
EP - 251
JO - International Journal of Stroke
JF - International Journal of Stroke
IS - 2
ER -