1. The REDOXS© Study REducing Deaths from OXidative Stress PART 3 of 4
REDOXS Training
The REDOXS© Study
REducing Deaths from OXidative Stress PART 3 of 4
Sponsor
Dr. Daren Heyland, MD, FRCPC
Project Leader
Rupinder Dhaliwal, BASc, RD
October 2007 1

2. Study Coordinator (Continued from Part 2)

3. Protocol Violation Protocol Deviation
Volume of study supplement actually received is less than the prescribed volume in 24hrs
Enteral < 80% prescribed
Parenteral <90% prescribed
Complete Violation Form within 24 hours of discovery
&
Fax to CERU
Attention: Project Leader
(613)
Enteral ≥ 80% < 100% prescribed
Parenteral ≥ 90% <100% prescribed
Provide explanation on the worksheet/web based data entry (Study Supplement Compliance)
Imp Manual: Protocol Violation

4. Protocol Violation Form

5. Vasopressors/Inotropes
Highest hourly dose received
Imp Manual: p 40

6. Concomitant Medications
What about decadron or solumedrol or
Solu-cortef?
Imp Manual: p 41

7. Input Warnings (must address before ICU Outcomes)
Imp Manual: p 47

8. ICU Outcomes
This page MUST be completed before you can proceed to the next web pages
Imp Manual: p 47

9. Locking of data OR after ICU infection adjudication
Can ask CERU to unlock the data to make changes
Imp Manual: p 50

10. Hospital Outcomes
Imp Manual: p 55

11. 3 and 6 month f/up
Imp Manual: p 57

12. SF-36 at 3 and 6 months
Imp Manual: p 59

13. Web entry and study day 1
Study day 1

14. Daily Monitoring Enteral Study Supplement Volumes
< 80 % prescribed: Protocol Violation Form
>= 80 and < 100 %: Provide explanation
Parenteral Study Supplement Volumes
< 90% prescribed: Protocol Violation Form
>=90 and < 100%: provide explanation
SAEs: unexpected: report within 48 hrs, 10 days
Start of antibiotics > 72 hrs ICU admit, ask SI
Positive Cultures > 72 hrs ICU admit: ask SI

15. Review: Duration of data collection
How long to collect data for the following patients
d/c from ICU at day 10
d/c from ICU at day 3 and continued on the ward
d/c from ICU at day 50

16. Threats to Success Poor enrollment, competing studies.
Inadequate delivery of study supplements.
Inadequate delivery of enteral nutrition.
Small bowel feeding tubes
pumps
Additional training needs?

17. www.criticalcarenutrition.com>REDOXS Study>Resources
Resources online
Study>Resources

18. REDOXS© Circular and Bulletin
Questions??
Imp Manual Tools
REDOXS© Circular and Bulletin