The REDOXS © Study REducing Deaths from OXidative Stress Part 3 of 3 Sponsor Dr. Daren Heyland, MD,...
-
Upload
quentin-greene -
Category
Documents
-
view
216 -
download
0
Transcript of The REDOXS © Study REducing Deaths from OXidative Stress Part 3 of 3 Sponsor Dr. Daren Heyland, MD,...
![Page 1: The REDOXS © Study REducing Deaths from OXidative Stress Part 3 of 3 Sponsor Dr. Daren Heyland, MD, FRCPC Project Leader Rupinder Dhaliwal, BASc, RD.](https://reader035.fdocuments.us/reader035/viewer/2022062408/56649ee45503460f94bf3885/html5/thumbnails/1.jpg)
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
![Page 2: The REDOXS © Study REducing Deaths from OXidative Stress Part 3 of 3 Sponsor Dr. Daren Heyland, MD, FRCPC Project Leader Rupinder Dhaliwal, BASc, RD.](https://reader035.fdocuments.us/reader035/viewer/2022062408/56649ee45503460f94bf3885/html5/thumbnails/2.jpg)
Pharmacy
![Page 3: The REDOXS © Study REducing Deaths from OXidative Stress Part 3 of 3 Sponsor Dr. Daren Heyland, MD, FRCPC Project Leader Rupinder Dhaliwal, BASc, RD.](https://reader035.fdocuments.us/reader035/viewer/2022062408/56649ee45503460f94bf3885/html5/thumbnails/3.jpg)
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
![Page 4: The REDOXS © Study REducing Deaths from OXidative Stress Part 3 of 3 Sponsor Dr. Daren Heyland, MD, FRCPC Project Leader Rupinder Dhaliwal, BASc, RD.](https://reader035.fdocuments.us/reader035/viewer/2022062408/56649ee45503460f94bf3885/html5/thumbnails/4.jpg)
Pharmacy Treatment assignment
Note: this is not the randomization list that will be used for the study.
Pharm Manual p 6
![Page 5: The REDOXS © Study REducing Deaths from OXidative Stress Part 3 of 3 Sponsor Dr. Daren Heyland, MD, FRCPC Project Leader Rupinder Dhaliwal, BASc, RD.](https://reader035.fdocuments.us/reader035/viewer/2022062408/56649ee45503460f94bf3885/html5/thumbnails/5.jpg)
Supply of Supplements
• Fresenius Kabi
• Selenium from Pharmacy (TBD)
• Before start: Supplies to be shipped to sites
• Need updated pharmacy contact and shipping address
![Page 6: The REDOXS © Study REducing Deaths from OXidative Stress Part 3 of 3 Sponsor Dr. Daren Heyland, MD, FRCPC Project Leader Rupinder Dhaliwal, BASc, RD.](https://reader035.fdocuments.us/reader035/viewer/2022062408/56649ee45503460f94bf3885/html5/thumbnails/6.jpg)
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
![Page 7: The REDOXS © Study REducing Deaths from OXidative Stress Part 3 of 3 Sponsor Dr. Daren Heyland, MD, FRCPC Project Leader Rupinder Dhaliwal, BASc, RD.](https://reader035.fdocuments.us/reader035/viewer/2022062408/56649ee45503460f94bf3885/html5/thumbnails/7.jpg)
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
![Page 8: The REDOXS © Study REducing Deaths from OXidative Stress Part 3 of 3 Sponsor Dr. Daren Heyland, MD, FRCPC Project Leader Rupinder Dhaliwal, BASc, RD.](https://reader035.fdocuments.us/reader035/viewer/2022062408/56649ee45503460f94bf3885/html5/thumbnails/8.jpg)
Remove company label and staple to Form B
Attach pharmacy label to bottle
(maintain blinding)
Pharm Manual p 12, 13
![Page 9: The REDOXS © Study REducing Deaths from OXidative Stress Part 3 of 3 Sponsor Dr. Daren Heyland, MD, FRCPC Project Leader Rupinder Dhaliwal, BASc, RD.](https://reader035.fdocuments.us/reader035/viewer/2022062408/56649ee45503460f94bf3885/html5/thumbnails/9.jpg)
Enteral Dispensing LogPharm Manual p 14
![Page 10: The REDOXS © Study REducing Deaths from OXidative Stress Part 3 of 3 Sponsor Dr. Daren Heyland, MD, FRCPC Project Leader Rupinder Dhaliwal, BASc, RD.](https://reader035.fdocuments.us/reader035/viewer/2022062408/56649ee45503460f94bf3885/html5/thumbnails/10.jpg)
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
![Page 11: The REDOXS © Study REducing Deaths from OXidative Stress Part 3 of 3 Sponsor Dr. Daren Heyland, MD, FRCPC Project Leader Rupinder Dhaliwal, BASc, RD.](https://reader035.fdocuments.us/reader035/viewer/2022062408/56649ee45503460f94bf3885/html5/thumbnails/11.jpg)
Parenteral Worksheet: AOX
Pharm Manual p 15, 31-34
Refer to Revised
Worksheets November 2007
![Page 12: The REDOXS © Study REducing Deaths from OXidative Stress Part 3 of 3 Sponsor Dr. Daren Heyland, MD, FRCPC Project Leader Rupinder Dhaliwal, BASc, RD.](https://reader035.fdocuments.us/reader035/viewer/2022062408/56649ee45503460f94bf3885/html5/thumbnails/12.jpg)
Parenteral Worksheet: GLN
![Page 13: The REDOXS © Study REducing Deaths from OXidative Stress Part 3 of 3 Sponsor Dr. Daren Heyland, MD, FRCPC Project Leader Rupinder Dhaliwal, BASc, RD.](https://reader035.fdocuments.us/reader035/viewer/2022062408/56649ee45503460f94bf3885/html5/thumbnails/13.jpg)
Parenteral Worksheet: AOX+GLN
![Page 14: The REDOXS © Study REducing Deaths from OXidative Stress Part 3 of 3 Sponsor Dr. Daren Heyland, MD, FRCPC Project Leader Rupinder Dhaliwal, BASc, RD.](https://reader035.fdocuments.us/reader035/viewer/2022062408/56649ee45503460f94bf3885/html5/thumbnails/14.jpg)
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
![Page 15: The REDOXS © Study REducing Deaths from OXidative Stress Part 3 of 3 Sponsor Dr. Daren Heyland, MD, FRCPC Project Leader Rupinder Dhaliwal, BASc, RD.](https://reader035.fdocuments.us/reader035/viewer/2022062408/56649ee45503460f94bf3885/html5/thumbnails/15.jpg)
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
![Page 16: The REDOXS © Study REducing Deaths from OXidative Stress Part 3 of 3 Sponsor Dr. Daren Heyland, MD, FRCPC Project Leader Rupinder Dhaliwal, BASc, RD.](https://reader035.fdocuments.us/reader035/viewer/2022062408/56649ee45503460f94bf3885/html5/thumbnails/16.jpg)
Parenteral Study Supplement Log
Pharm Manual p 17
![Page 17: The REDOXS © Study REducing Deaths from OXidative Stress Part 3 of 3 Sponsor Dr. Daren Heyland, MD, FRCPC Project Leader Rupinder Dhaliwal, BASc, RD.](https://reader035.fdocuments.us/reader035/viewer/2022062408/56649ee45503460f94bf3885/html5/thumbnails/17.jpg)
Parenteral Label
Pharm Manual p 16, 35
![Page 18: The REDOXS © Study REducing Deaths from OXidative Stress Part 3 of 3 Sponsor Dr. Daren Heyland, MD, FRCPC Project Leader Rupinder Dhaliwal, BASc, RD.](https://reader035.fdocuments.us/reader035/viewer/2022062408/56649ee45503460f94bf3885/html5/thumbnails/18.jpg)
Nutrient Accountability LogsOne log for each product except
for normal saline
Pharm Manual p 19-25
![Page 19: The REDOXS © Study REducing Deaths from OXidative Stress Part 3 of 3 Sponsor Dr. Daren Heyland, MD, FRCPC Project Leader Rupinder Dhaliwal, BASc, RD.](https://reader035.fdocuments.us/reader035/viewer/2022062408/56649ee45503460f94bf3885/html5/thumbnails/19.jpg)
Monthly Site Inventory Log
Fax in to CERU monthly
Pharm Manual p 8,9
![Page 20: The REDOXS © Study REducing Deaths from OXidative Stress Part 3 of 3 Sponsor Dr. Daren Heyland, MD, FRCPC Project Leader Rupinder Dhaliwal, BASc, RD.](https://reader035.fdocuments.us/reader035/viewer/2022062408/56649ee45503460f94bf3885/html5/thumbnails/20.jpg)
Temperature Log
Fax in to CERU monthly
Pharm Manual p 10, 11
![Page 21: The REDOXS © Study REducing Deaths from OXidative Stress Part 3 of 3 Sponsor Dr. Daren Heyland, MD, FRCPC Project Leader Rupinder Dhaliwal, BASc, RD.](https://reader035.fdocuments.us/reader035/viewer/2022062408/56649ee45503460f94bf3885/html5/thumbnails/21.jpg)
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
![Page 22: The REDOXS © Study REducing Deaths from OXidative Stress Part 3 of 3 Sponsor Dr. Daren Heyland, MD, FRCPC Project Leader Rupinder Dhaliwal, BASc, RD.](https://reader035.fdocuments.us/reader035/viewer/2022062408/56649ee45503460f94bf3885/html5/thumbnails/22.jpg)
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
![Page 23: The REDOXS © Study REducing Deaths from OXidative Stress Part 3 of 3 Sponsor Dr. Daren Heyland, MD, FRCPC Project Leader Rupinder Dhaliwal, BASc, RD.](https://reader035.fdocuments.us/reader035/viewer/2022062408/56649ee45503460f94bf3885/html5/thumbnails/23.jpg)
REDOXS© Circular and Bulletin
Questions?? Imp Manual Tools