Stroke Hyperglycemia Insulin Network Effort (SHINE) Trial
The study (SHine) is a multi-center, randomized, controlled clinical trial of approximately 1400 patients to be conducted at 17 neurological emergencies Treatment Trials (neTT) hubs and their spoke hospitals as well as approximately 10 non-neTT sites for a total of some 56 sites nationwide. The study population will include hyperglycemic acute ischemic stroke patients of either gender who are 18 years of age or older. They will have a history of type 2 diabetes and hyperglycemia or in the absence of diabetes, must have a baseline glucose levels [Greater Than] or equal to 150 mg/dL. The project period will be expected to begin in 2012 and take 3.5-4 years and follow up is 3 months. i was unable to include the table in this section so i attached in the 6.3.1 portion with the protocol to better assist members of the iRB in identifying the two study arms (intervention and control). The treatment arms consist of two groups. The intervention Group will be placed on and iV insulin drip - rate determined by the Glucostablalizer intervention Decision Tool (computer program supplied on the SHine study laptop assigned to each participant). next, depending on whether the patient is nPo or continuous Tube Feeding versus bolus tube feeding or eating a 60 GM CHo meal 3 times a day will depend on the interventions which will be implemented. if nPo or continuous tube feeding then at 0900 and 2100 the patient will have a fingerstick glucose, the result entered into Glucostabalizer, and the computer program will instruct the nurse to give 0.5 ml nS in a 1 ml syringe -SQ placebo injection; the patient will receive only iV insulin and no SQ insulin, only SQ nS. if the patient is eating or having bolus tube feedings they will receive iV insulin infusion and 3 times a day will have a fingerstick before the meal at 0600, 1200, and 1800 with SQ nS injections. in addition to the iV insulin each patient will be given a 60 gram CHo diet. at 20 minutes after the patient begins to consume the meal or be tube fed, the nurse will come in and put the amount eaten or estimated amount then per Glucostabalizer the patient will receive and the computer program will suggest a dose of Subcutaneous Meal insulin or Saline injections with a Target Glucose Concentration of 80-130mg/dL. The control group arm which implements iV Saline with Subcutaneous insulin injections with a target blood glucose [Less Than]180 mg/dL. if a patient in the control group both interventions are the same no matter the route of receiving calories then they will have point of care fingersticks q 3 hours the result entered in Glucostabalizer; however the dosing of SQ Regular insulin times will be at 0600,1200,1800,2400. also the nurse will be told at what rate to run the iV nS drip.
The key fact to remember is all subjects will receive insulin in one form: iV or SQ and will differ depending on which arm the subjects are randomized to. additionally, for the control group if they progress up the sliding scale insulin table and achieve the third level on the final day they will receive a single dose of basal (Lantus) insulin.
if the patient becomes hypoglycemic then the Glucostabalizer will tell the nurse to implement the hypoglycemia protocol by turning off the insulin drip and give a dose of D50W. The D50 will be stored to allow immediate availability at the bedside. if a patient in either group becomes hypoglycemic ([Less Than]70 mg/dL), iV D50 25 mL (1/2 amp D50).will be given.
Continue fingerstick glucose levels q 15 min per Glucostabalizer X 4 or until glucose level is back [Greater Than]80 mg/dL. Lastly, the patient cannot consume any snacks or food brought in from outside the hospital, oR the family cannot eat from patient's tray.
(1) Age 18 years or older
(2) Clinical diagnosis of ischemic stroke defined as acute neurological deficit occurring in one or more cerebral vascular territories. Neuroimaging must be done to exclude intracranial hemorrhage (ICH).
(3) Protocol treatment must begin within 12 hours after stroke symptom onset and is recommended, but not required, to begin within 3 hours of hospital arrival. If time of symptom onset is unclear or patient is awakening with stroke symptoms, the time of onset will be the time the patient was last known to be normal.
(4) Known history of type 2 diabetes mellitus and glucose >110 mg/dL OR admission glucose >=150 mg/dL in those w/o known diabetes mellitus
(5) Baseline NIHSS score of 3-22
(6) Pre-stroke Modified Rankin Scale score = 0 for patients with an NIHSS score of 3-7. Pre-stroke modified Rankin Scale score = 0 or 1 for patient with an NIHSS score of 8-22.
(7) Able to provide a valid informed consent to be in the study (self or their
authorized legally accepted representative). The approved consent form
must be signed and dated in accordance with federal and institutional guidelines.
For the substudy ISPOT, we are accepting a small number of patients (90) who have received IV tPA. All other inclusion and exclusion criteria remain the same for the parent study, SHINE.