The REDOXS © Study REducing Deaths from OXidative Stress Part 3 of 3 Sponsor Dr. Daren Heyland, MD, FRCPC Project Leader Rupinder Dhaliwal, BASc, RD

Pharmacy

Pharmacy Log In Check if you need to configure web browser BEFORE your enrol ! Pharm Manual p 5 Passwords assigned once regulatory approvals in place

Pharmacy Treatment assignment Note: this is not the randomization list that will be used for the study. Pharm Manual p 6

Supply of Supplements Fresenius Kabi Selenium from Pharmacy (TBD) Before start: Supplies to be shipped to sites Need updated pharmacy contact and shipping address

Dispensing ICU pharmacist  dispensing pharmacist Sign signature log Enteral supplements –no mixing needed Parenteral supplements –Mixing required: Dipeptiven (Glutamine) + Selenium (AOX) + Normal Saline If hypernatremia, can be mixed in with D5W instead of saline! Pharm Manual p 12

Enteral Products Obtain appropriate enteral product Infuse at 20 ml/hour for all patients Generate pharmacy label (need 2 labels) Pharm Manual p 12, 29

Remove company label and staple to Form B Attach pharmacy label to bottle (maintain blinding) Pharm Manual p 12, 13

Enteral Dispensing Log Pharm Manual p 14

Mixing of Parenteral Supplements Dipeptiven (Glutamine) + Selenium (AOX) + Normal Saline Final volume = 250 mls, hourly rate = 10 ml/hr. 1. Determine dose of Glutamine according to Normal weight Normal Weight (kg) = height (cms) –100 cms Dose of Dipeptiven = Normal wt. X 2.5 mls (This equals to Normal wt. X 0.35 gms of Glutamine or Normal weight X 0.5 gms of L-alanyl-L-Glutamine). 2. Dose of Selenium = 12.5 ml (500 micrograms) = 1.25 vial EU sites: dose is 10 mls (500 micrograms 3. Combine the Glutamine + Selenium and remove this volume from 250 ml of normal saline. 4. Replace normal saline with this mixture. Final volume =250 mls. Pharm Manual p 15

Parenteral Worksheet: AOX Pharm Manual p 15, Refer to Revised Worksheets November 2007

Parenteral Worksheet: GLN

Parenteral Worksheet: AOX+GLN

Dosages according to height (PN) If > 6 feet 5 inches (>196 cms) Final volume of parenteral solution will be between mls. Can still use 250 mls bag of saline If no normal saline to be used, use an empty sterile bag and add supplements to the bag (instead of removing all normal saline) Final rate of solution will exceed 10 ml/hr Central line needed but peripheral may be used (72 hrs max) Pilot Study: no one > 190 cms (6’3”) Pharm Manual p 18, 36 Refer to Revised Worksheets November 2007

Expiration of Supplements Selenium once opened: 24 hrs if refrigerated Dipeptiven once opened: mix immediately Once mixed, parenteral solutions have an expiration of 96 hrs room temperature –Can make in batches to last 3 days!! Enteral Supplements once opened: 24 hrs Pharm Manual p 10

Parenteral Study Supplement Log Pharm Manual p 17

Parenteral Label Pharm Manual p 16, 35

Nutrient Accountability Logs One log for each product except for normal saline Pharm Manual p 19-25

Monthly Site Inventory Log Fax in to CERU monthly Pharm Manual p 8,9

Temperature Log Fax in to CERU monthly Pharm Manual p 10, 11

Case Study: Dosing error REDOXS Pharmacist away for weekend and returns on Monday and after reviewing logs realizes that Mr. J.S accidentally received the wrong supplements. Should have received GLN but received GLN+AOX instead for the last 18 hours. What to do? 1.Stop the infusion immediately 2.Inform research coordinator ASAP, maintain blinding 3.Notify CERU immediately, Note to File 4.Steps to prevent recurrence

FAQs Pharmacy Keep vials of returned/destroyed products? One password for all Pharmacists/technicians? Pharmacist or technician that dispenses the supplements? P. Manual page 16

REDOXS © Circular and Bulletin Questions?? Imp Manual Tools