The REDOXS© Study REducing Deaths from OXidative Stress PART 3 of 4

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Presentation transcript:

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

Study Coordinator (Continued from Part 2)

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) 548-2428 Enteral ≥ 80% < 100% prescribed Parenteral ≥ 90% <100% prescribed Provide explanation on the worksheet/web based data entry (Study Supplement Compliance) Imp Manual: Protocol Violation

Protocol Violation Form

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

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

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

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

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

Hospital Outcomes Imp Manual: p 55

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

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

Web entry and study day 1 Study day 1

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

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

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?

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

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