The REDOXS© Study REducing Deaths from OXidative Stress Part 1 of 3

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Presentation transcript:

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

Administration of Study Supplements

Parenteral Supplement Study Groups Enteral Supplement Parenteral Supplement GLN +AOX Glutamine + AOX Dipeptiven + Selenium AOX AOX only Placebo + Selenium GLN Glutamine only Dipeptiven + Placebo Placebo Placebo + Placebo SC blinded Pharmacist unblinded

Enteral Study Supplement EN REDOXS © Formula

Parenteral Study Supplements (Dipeptiven and Selenium) +

Enteral Nutrition ENTERAL REDOXS formula PARENTERAL REDOXS formula (but will be in a normal saline type bag) Jevity and ENTERAL REDOXS being “Y”-ed in using Y connector

Study Supplements Pharmacist is unblinded Supplements to start ASAP SS Manual p 4-10 Study Supplements Pharmacist is unblinded Supplements to start ASAP within 24 hrs of admission to ICU within 2 hrs of randomization Duration: 28 days or death or ICU discharge min of 5 days IF transferred to ward, if not until ICU d/c Continuous infusion X 24 hrs but can be doubled up (12 hrs max)

Infusion of Supplements REDOXS Training Infusion of Supplements Parenteral supplements as soon as patient resuscitated 10 ml/hr dedicated central port (eg. one of a triple lumen) can run peripherally if needed (watch for phlebitis) Do NOT infuse with medications; IV fluids, albumin, nutrition OK Enteral supplement NG tube OK or feeding tube 20 ml/hr, can be given via Y connector start regardless of whether MDs want to start enteral nutrition nutrients vs. nutrition October 2007

Template of Study Orders Study Supplement Manual Page 11 Imp. Manual: Tools To optimize delivery of supplements Study day 1= ICU admission until end of your flowsheet

REDOXS© Teamwork Site Investigator Pharmacist Dietitian Regulatory Inclusion/exclusion criteria ICU infection adjudication SAE reporting Pharmacist Checking allocation Dispensing Logs Dietitian Optimizing nutrition Monitoring Adequacy Study Coordinator Regulatory Screening/Randomization Pharmacy communication Data collection Supplement monitoring Collaboration with SI SAE reporting Protocol Violation reporting