Stroke Hyperglycemia Insulin Network Effort (SHINE) Trial Treatment Protocols. Askiel Bruno, MD, MS Protocol PI
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1 Stroke Hyperglycemia Insulin Network Effort (SHINE) Trial Treatment Protocols Askiel Bruno, MD, MS Protocol PI
2 SHINE Synopsis Acute ischemic stroke <12 hrs (onset) and <3 hrs (arrival) Baseline blood glucose >110 mg/dl if a known diabetic (type 2) 150 mg/dl if not a known diabetic Baseline NIHSS 3-22 Randomized, initially single blind final outcome double blind N=1400 Control group: SQ insulin only (glu range mg/dl) x 72 hrs Intervention group: Sq insulin with meals and IV insulin drip (glu target mg/dl) x 72 hrs Final outcome - 3 month mrs
3 SHINE Synopsis Control Intervention SQ injections IV drip
4 Treatment Groups General Concepts BG range mg/dl Control SQ insulin (regular human) per sliding scale IV saline drip (to mimic IV insulin drip to maintain blind) Q1 hr glucose checks for 1 st 4 hrs only Q3 hr glucose checks after that but insulin given only at 06:00, 12:00, 18:00 and 24:00 if indicated Basal insulin (slow acting) only at 48 hrs if indicated
5 Treatment Groups General Concepts BG target mg/dl Intervention Glucose checks and IV insulin (regular human) drip adjustments per GlucoStabilizer (computer decision support tool) When not eating, SQ saline (to mimic SQ insulin to maintain blind) When eating, SQ meal insulin (rapid acting analog) per meal carbohydrate intake
6 Detailed Look at Control Group Initiation of Treatment Notify pharmacy Start SHINE laptop and click on Control Group Re-check glucose when IV saline is ready Start IV saline infusion per protocol (on screen) and adjust as needed with each glucose check Check glucose q 1hr x4, then q 3hr Give insulin per sliding scale at 06:00, 12:00, 18:00 and 24:00 Control Group Computer Screen
7 Getting Started
8 Control Group Computer Screen
9 Control Group Documenting
10 Detailed Look at Control Group Continuation of Treatment Check glucose on schedule Give SQ insulin only at the designated times, if indicated by the sliding scale ( 180 mg/dl); 1 st 24 hrs SQ insulin scale Level is 1 Adjust IV saline rate if indicated after each glucose check Same procedure whether eating or not Control Group Computer Screen
11 Control Group Computer Screen
12 SHINE Allowed Insulins Insulin Treatment Type Control Intervention SQ sliding scale Regular human: Not Allowed Humulin R, Novolin R SQ basal Slow acting: Not Allowed glargine (Lantus) ONLY Rapid acting analog: humalog (Lispro), novolog SQ meal Not Allowed (Aspart), glulisine (Apidra) IV Not Allowed Regular human: Humulin R, Novolin R Insulin syringes Yes Yes Insulin pens NO NO
13 Sliding Scale Insulin Level Changes All patients on level 1 for first 24 hours At end of 1 st 24 hrs (any time of day) advance to Level 2 only if the latest 2 glucose levels 180 mg/dl; otherwise stay on Level 1 At end of 48 hrs (any time of day) advance to next level (2 or 3) only if the latest 2 glucose levels 180 mg/dl; otherwise stay on current Level Level 3 involves SQ basal, slow acting, insulin (Lantus) given once at end of 48 hrs, and the sliding scale insulin doses for Level 3 are the same as Level 2 Advance level only if indicated at end of 24 and 48 hrs
14 Sliding Scale Insulin Level Changes Start Protocol End of 24 hrs End of 48 hrs Level 3 Level 2 Level 1 Level 2 Level 1 Level 1
15 Level 3 Control Treatment Basal Insulin Level 3 is different - only one with basal insulin Calculating basal insulin dose - add up all the insulin units given in the previous 24 hrs (25th to end of 48th hr period) available in the SHINE computer; 40% of that total is the dose of basal insulin (x 0.4) to be given once at end of 48 hrs; use only glargine (Lantus) insulin for this After the one dose of SQ basal insulin continue SQ sliding scale insulin Level 3 (the same as Level 2 sliding scale)
16 Control Group - Meals 60 gram carbohydrate diet should be ordered NO estimate of meal consumption required and NO meal insulin given in control group (only SQ sliding scale insulin at 06:00, 12:00, 18:00 and 24:00 if indicated Pts should eat only after their glucose check and the SQ insulin has been given as needed at 6:00, 12:00, and 18:00. (If meal arrives before these times, hold until one of these specified times.) Remember not to provide extra meals or any between meal snacks during the 72 hr SHINE treatment protocol.
17 Data Entry Standard chart documentation All glucose/insulin data entry in GlucoStabilizer (details discussed in afternoon session)
18 Detailed Look at Intervention Group Initiation of Treatment Notify pharmacy Start SHINE laptop and click Intervention Group Re-check glucose when IV solution is ready Start IV insulin infusion per GlucoStabilizer recs Intervention Group Computer Screen
19 Getting Started
20 Intervention Group Computer Screen
21 Detailed Look at Intervention Group Continuation of Treatment Recheck and enter glucose in GlucoStabilizer Adjust IV insulin drip per GlucoStabilizer recs When patient is not eating give SQ saline 0.05 cc at ~9 a.m. and ~9 p.m. after glucose checks, to simulate the 0-4 SQ insulin injections in the control group When patient is eating give meal insulin per protocol
22 Intervention Group Meals Breakfast, Lunch, Dinner opportunity for meal insulin When patient cleared to eat order 60g carbohydrate diet Allow 20 minutes from start of eating then estimate the proportion of meal that was consumed
23 Intervention Group SQ Meal Insulin Dosing Meal consumed all or nearly all Enter 60 carb meal into GlucoStabilizer Give dose of meal insulin recommended Meal consumed none or nearly none DO NOT make an entry into GlucoStabilizer Give NO meal insulin Meal consumed in between Enter 30 carb meal into GlucoStabilizer Give dose of meal insulin recommended NO extra meals during 1 st 72 hrs
24 Intervention Group Meal Insulin Computer Screens
25 Glucose/Insulin Data Entry Standard chart documentation All glucose/insulin data entry in GlucoStabilizer (discussed in afternoon session in detail)
26 Additional Special Situations Reviewed in next session Hypoglycemia protocol How to sync glucose checks in control group Protocol pauses Tube feeds Early discharge Discontinuation of protocol treatment
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