The REDOXS© Study REducing Deaths due to OXidative Stress

The REDOXS© StudyREducing Deaths from OXidative Stress

Part 3 of 3Sponsor

Dr. Daren Heyland, MD, FRCPC

Project LeaderRupinder 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 LogPharm Manual p 14

Mixing of Parenteral SupplementsDipeptiven (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, 31-34

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 250-300 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 LogsOne 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 errorREDOXS 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