Transcript REDOXS© Trial Pilot - Critical Care Nutrition

©
The REDOXS Study
REducing Deaths due to OXidative Stress
The REDOXS© Study
REducing Deaths from OXidative Stress
Part 1 of 3
Sponsor
Dr. Daren Heyland, MD, FRCPC
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Project Leader
Rupinder Dhaliwal, BASc, RD
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Administration of Study
Supplements
Study Groups
GLN +AOX
Enteral
Supplement
Parenteral
Supplement
Glutamine + AOX
Dipeptiven +
Selenium
Placebo +
Selenium
Dipeptiven +
Placebo
Placebo +
Placebo
AOX
AOX only
GLN
Glutamine only
Placebo
SC blinded
Placebo
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
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
• 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
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
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REDOXS
Teamwork
Site Investigator
Pharmacist
Regulatory
Inclusion/exclusion criteria
ICU infection adjudication
SAE reporting
Checking allocation
Dispensing
Logs
Dietitian
Study Coordinator
Regulatory
Screening/Randomization
Pharmacy communication
Data collection
Supplement monitoring
Collaboration with SI
SAE reporting
Protocol Violation reporting
Optimizing nutrition
Monitoring Adequacy