Stroke Hyperglycemia Insulin Network Effort (SHINE) Trial Treatment Protocol Cases

Case #1 Timing of Checks/Dosing in the Control Group

Case #1 You just enrolled a patient in the control group. You randomized at 9:33 AM. You do your initiation check and start the saline drip at 10:35 AM. Question 1: What are the times of your next hourly checks? When is your first Q3 hourly check? a)11:35, 12:35, 13:35, 15:00 b)11:35, 12:35, 13:35, 14:35, 18:00 c)12:00, 15:00, 18:00, 21:00 d)11:35, 12:35, 13:35, 14:35, 17:35

Case #1 You just enrolled a patient in the control group. You randomized at 9:33 AM. You do your initiation check and start the saline drip at 10:35 AM. Question 1: What are the times of your next hourly checks? When is your first Q3 hourly check? a)11:35, 12:35, 13:35, 15:00 b)11:35, 12:35, 13:35, 14:35, 18:00 (Correct) c)12:00, 15:00, 18:00, 21:00 d)11:35, 12:35, 13:35, 14:35, 17:35

Case #1 – Answer 1 Rationale a)11:35, 12:35, 13:35, 15:00 (Incorrect – missing 1 hourly check before transitioning to q3 hr schedule) b)11:35, 12:35, 13:35, 14:35, 18:00 (Correct – 1 check to start at 10:35 and then 4 hourly checks. Transition to q3 hr schedule, skipping 15:00 check since prev check was within 1 hr and not a dosing time c)12:00, 15:00, 18:00, 21:00 (Incorrect –hourly checks should be 1 hr +/-15 minutes from the time that the infusion starts for 4 hours and then transition to the schedule for Q3 hr checks) d)11:35, 12:35, 13:35, 14:35, 17:35 (Incorrect –when transitioning to the q3 hr schedule, the checks should be at 3, 6, 9, 12, 15, 18, 21, 24 with a window of +/-15 min)

Timing of checks in the control group Q1 hr checks for 1 st 4 hrs = a total of 5 hourly checks – Check to start infusion: __:__ – 1st hourly check: _ _:_ _ (due 60 min from check to start) – 2nd hourly check:_ _:_ _ – 3rd hourly check: _ _:_ _ – 4th hourly check: _ _:_ _ Then transition to Q3 hour checks – 3, 6, 9, 12, 15, 18, 21, 24 (on the hour)

Case #1 You just enrolled a patient in the control group. You randomized at 9:33 AM. You do your initiation check and start the saline drip at 10:35 AM. Question 2: When will you dose with SQ insulin? a)11:35, 12:35 (dose), 13:35, 14:35, 18:00 (dose) b)11:35, 12:35, 13:35, 14:35, 18:00 (dose) c)11:35 (dose), 12:35, 13:35, 14:35, 18:00 (dose) d)Give SQ insulin with EACH glucose check

Case #1 You just enrolled a patient in the control group. You randomized at 9:33 AM. You do your initiation check and start the saline drip at 10:35 AM. Question 2: When will you dose with SQ insulin? a)11:35, 12:35 (dose), 13:35, 14:35, 18:00 (dose) b)11:35, 12:35, 13:35, 14:35, 18:00 (dose) c)11:35 (dose), 12:35, 13:35, 14:35, 18:00 (dose) d)Give SQ insulin with EACH glucose check

Case #1 – Answer 2 Rationale a)11:35, 12:35 (dose), 13:35, 14:35, 18:00 (dose) (Incorrect- SQ insulin should be given at 11:35 check since within 30 min) b)11:35, 12:35, 13:35, 14:35, 18:00 (dose) (Incorrect – since 11:35 is within 30 minutes of dosing time, give SQ insulin at the time of that check) c)11:35 (dose), 12:35, 13:35, 14:35, 18:00 (dose) (Correct - 11:35 is within 30 minutes of dosing time, give SQ insulin at the time of that check; next scheduled dosing time is 18:00) d)Give SQ insulin with EACH glucose check (Incorrect- SQ insulin should only be given at the scheduled dosing times of 6, 12, 18 and 24:00)

Dosing in the Control Group IV saline – adjust with EACH glucose check SQ regular insulin – given, if indicated per sliding scale, ONLY at 6/12/18/24 – If within 30 min of the next dosing time during hourly checks, dose – If cross a dosing time during hourly checks, dose (i.e. 1 st check at 11:21, 2 nd check at 12:21  dose) Basal insulin – one-time dose ONLY for pts that advance to Level 3 at 48 hours

Dosing in the Control Group 13 2

Questions on Checks/Dosing in Control Group?

Case #2 Level Changes in the Control Group

Case #2 You are finishing Day 2 on the protocol on Level 2 in the control group, and the 48 hour mark is at 9:33 AM. The last glucose checks are: Note: 24 hr mark is 9:33 Question 1: What is the sliding scale level at 48 hours? a) Level 1b) Level 2c) Level 3 Note: 48 hr mark is 9:33 TimeGlucoseSQ insulin 9AM2990 6AM1934 3AM AM1480 9PM2120 6PM1894 3PM PM2076 9AM1990

Case #2 You are finishing Day 2 on the protocol on Level 2 in the control group, and the 48 hour mark is at 9:33 AM. The last glucose checks are: TimeGlucoseSQ insulin 9AM2990 6AM1934 3AM AM1480 9PM2120 6PM1894 3PM PM2076 9AM1990 Note: 24 hr mark is 9:33 Question 1: What is the sliding scale level at 48 hours? a) Level 1b) Level 2c) Level 3 Note: 48 hr mark is 9:33

Case #2 – Answer 1 Rationale a)Level 1 (Incorrect – All patients start at Level 1 with the opportunity to advance at 24 and 48 hours from randomization. The only time that a pt would move backwards or to a lower level would be per the recommendation of the safety monitor. b)Level 2 (Incorrect –Pt was at Level 2 from hrs. Previous 2 glucose checks just before 48 hour mark were 299 and 192. Since both are >180, advance to Level 3. Another way of thinking of this is that if either of the 2 glucose levels were in target (<180mg/dL), do NOT advance to the next level.) c)Level 3 (Correct – Pt was at Level 2 from hrs. Previous 2 glucose checks just before 48 hour mark were 299 and 192. Since both are >180, advance to Level 3.

Control Group – Level Changes Level changes allow increase in insulin coverage for subjects who need higher dosing All patients on Level 1 for first 24 hrs Level changes assessed every 24 hrs from time of randomization Advance to next level at 24 and 48 hrs if latest two glucose results are > 180mg/dL

Case #2 You are finishing Day 2 on the protocol in the control group, and the 48 hour mark is at 9:33 AM. The last 2 glucose checks were 299 and 193 so you advanced to Level 3. Question 2: What dose of Lantus/glargine (basal insulin) will you give? a)40% of 2 previous SQ insulin doses b)40% of all SQ insulin given in the past 24 hours c)50% of 2 previous SQ insulin doses d)50% of all SQ insulin given in the past 24 hours

Case #2 You are finishing Day 2 on the protocol in the control group, and the 48 hour mark is at 9:33 AM. The last 2 glucose checks were 299 and 193 so you advanced to Level 3. Question 2: What dose of Lantus/glargine (basal insulin) will you give? a)40% of 2 previous SQ insulin doses b)40% of all SQ insulin given in the past 24 hours c)50% of 2 previous SQ insulin doses d)50% of all SQ insulin given in the past 24 hours

Case #2– Answer 2 Rationale a)40% of 2 previous SQ insulin doses. (Incorrect– When assessing for level changes at 24 and 48 hours, consider the two previous glucose levels. When determining the basal insulin dose, consider the total SQ insulin given in the prev 24 hrs) b)40% of all SQ insulin given in the past 24 hours. (Correct- When determining the dose of basal insulin to give, add up the total insulin SQ given in the prev 24 hrs and multiply by 0.4.) c)50% of 2 previous SQ insulin doses. (Incorrect– The Lantus/ glargine dose is 40% of the total insulin given in the prev 24 hrs.) d)50% of all SQ insulin given in the past 24 hours. (Incorrect– The Lantus/glargine dose is 40% of the total insulin given in the previous 24 hours.)

Case #2 TimeGlucoseSQ insulin 9AM2990 6AM1934 3AM AM1480 9PM2120 6PM1894 3PM PM2076 9AM1990 Note: 24 hr mark is 9:33 Calculating the Lantus/glargine dose Total SQ insulin in prev 24 hrs * * 0.4 = 5.6 (round up if >.5 and down if <.4) = 6U Lantus Note: 48 hr mark is 9:33 Total SQ insulin

Case #2 You have reviewed the previous 2 glucose levels at 48 hrs and decided to advance to Level 3. The dose was calculated based of all of the SQ insulin given in the prev 24 hrs. Question 3: When do you give the Lantus/glargine? a)As close to 9:33 as possible (48 hrs from the time of randomization) b)12:00 (the next scheduled SQ regular insulin dosing time) c)As close to 10:35 as possible (48 hr from time of start of IV saline infusion)

Case #2 You have reviewed the previous 2 glucose levels at 48 hrs and decided to advance to Level 3. The dose was calculated based of all of the SQ insulin given in the prev 24 hrs. Question 3: When do you give the Lantus/glargine? a)As close to 9:33 as possible (48 hrs from the time of randomization) b)12:00 (the next scheduled SQ regular insulin dosing time) c)As close to 10:35 as possible (48 hr from time of start of IV saline infusion)

Case #2– Answer 3 Rationale a)As close to 9:33 as possible (48 hrs from the time of randomization) (Correct- Basal Insulin is given 48 hours from the time of randomization) b)12:00 (the next scheduled SQ regular insulin dosing time). (Incorrect-Give basal insulin as close to 48 hours from the time of randomization) c)As close to 10:35 as possible (48 hr from time of start of IV saline infusion) (Incorrect- Give basal insulin as close to 48 hours from the time of randomization)

Control Group - Level 3 Advance to Level 3 at 48 hrs if latest two glucose results are > 180mg/dL Level 3 includes a one-time dose of basal insulin SQ (glargine/Lantus) at 48 hrs from randomization Calculating basal insulin dose – Add all insulin given in previous 24 hrs (all 4 doses) – 40% of that total is the dose of basal insulin (>.5, round up) Basal insulin given SQ now (at 48 hrs) Continue schedule for checks and SQ sliding scale insulin dosing per Level 3

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