The REDOXS © Study REducing Deaths from OXidative Stress Dietitian and Pharmacy Training March 2009...
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Transcript of The REDOXS © Study REducing Deaths from OXidative Stress Dietitian and Pharmacy Training March 2009...
The REDOXS© Study REducing Deaths due to OXidative Stress
The REDOXS© StudyREducing Deaths from OXidative Stress
Dietitian and Pharmacy TrainingMarch 2009
Study ChairDr. Daren Heyland, MD, FRCPC
Project LeadersRupinder Dhaliwal, RD and Janet Overvelde
Administration of Study Supplements
Duration of study supplements
Maximum 28 days
Minimum 5 days: In patients with ICU LOS < 5 days and get discharged to ward
Enteral Supplement
Parenteral Supplement
GLN +AOX Glutamine + AOX Dipeptiven + Selenium
AOX AOX only Placebo + Selenium
GLN Glutamine only Dipeptiven + Placebo
Placebo PlaceboPlacebo + Placebo
Study Groups
SC blinded Pharmacist unblinded
Enteral Study Supplement EN REDOXS © Formula
Parenteral Study Supplements (Dipeptiven and Selenium)
+
US Product: selenium injection
EU: selenase (Biosyn)
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)
SS Manual p 4-10
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– May piggyback with IV fluids, albumin, PN (no heparin/insulin)
• 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
• Minimize interruptions, make up volume– Infuse at double rate for 12 hrs maximum on Day 1
• Intolerance to enteral feeding ( refer to feeding protocol)
• Other enteral formulas, vitamins, minerals• Renal Dysfunction
– Switch to lower protein formula– Restrict fluid– Refer to appendix (page 12)
If received volumes < Prescribed = Protocol Violation……….notify Methods Centre !!
SS Manual p 10-16
Template of Study OrdersStudy Supplement Manual Page 11
Imp. Manual: Tools
To optimize delivery of
supplements
Study day 1= ICU admission
until end of your flowsheet
ENTERAL REDOXS formula PARENTERAL
REDOXS formula (but will be in a normal saline type bag)
Enteral Nutrition (EN)
EN and ENTERAL REDOXS being “Y”-ed in
Role of the Dietitian
Optimizing Enteral Nutrition
Canadian CPGs
www.criticalcarenutrition.com
Feeding Protocol
Glycemic Protocol
Elevate the Head of the Bed
Motility Agents
Small Bowel Feeding
RD manual p 13
SS Manual p 16
Baseline Nutrition
Dietitian to collect:• Prescribed kcal and
protein (baseline)• Type of nutrition
support• Start and stop date and
times• Refer to Dietitian
Manual
RD Manual p 5,6
Imp Manual p 29,30
Daily Nutrition Data
Dietitian to collect
(for max 30 days):• Energy protein intake
• Add propofol
• Interruptions
• Type of enteral formula
• + location of feeding tube (daily data)
Collection in real time essential !
RD Manual p 7,11
Imp Manual p 37-39
Dietitian Checklist Imp Manual: Tools
RD Manual: 19,20
Checklist is a tool…refer to webpage for data to be entered in eCRF
July 31st 2008 version online
Propofol ≥ 6 hrs
Include in daily calories received as follows:– If on EN only, add to EN calories– If on PN only, add to PN calories– If on EN + PN, add to PN calories
Do not add if not receiving EN or PN
Study Supplement Compliance
• Volumes must be monitored DAILY in real time by Study Coordinator.
• If volumes < prescribed, need to report to CERU or provide explanation and take action to prevent recurrence.
Protocol Violation
Protocol Deviation
Imp Manual p 34
Study Coordinator
Study Coordinator to ensure compliance
Dietitian to help
• Maximize EN nutrient and nutrition delivery – use of feeding protocols– small bowel feeding
• Minimize interruptions, make up volume• Other enteral formulas with supplemental glutamine, vitamins,
minerals not allowed– No supplements with high amounts of Zinc (5 mg max)
• Renal Dysfunction– Switch to lower protein formula– Restrict fluid– Refer to appendix
If received volumes < Prescribed = Protocol Violation……….Study Coordinator to notify Methods Centre !!
Pilot study: Interruptions due to high urea only in2% patient days (9% patients)
RD Manual p 12-17
Case study: High GRVs
Mr. Smith who is 4 days post laporotomy (findings show bowel is not compromised) has had high gastric residual volumes > 500 mls for the last 48 hours. His enteral feeds have been interrupted several times and are now on hold. The MD in charge has also stopped the enteral study supplements to give the gut a rest and he now wishes to start parenteral nutrition.
What to do?
FAQs
• What if the prescribed calories and protein changes over the 28 days of the study duration?
• How do I get a prescribed calorie/protein level if the dietitian has not assessed this?
Daily Monitoring
Dietitian• Enteral Nutrition Adequacy
Study Coordinator• 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
Pharmacy
Supply of Supplements
• Fresenius Kabi: Dipeptiven, EN REDOXS
• Selenium: BIOSYN (EU), Baxter (Canada) or Pharmacy to purchase on own* (US)
• Before start: Supplies to be shipped to sites once Ethics approval received
• Need updated pharmacy contact and shipping address
*US sites: refer to Work Instruction for Selenium
Pharmacy Web Access To be completed by 2 of the most responsible pharmacists or technicians
Password can be shared by all pharmacy staff
Pharmacy Manual p 4
The REDOXS© Study REducing Deaths due to OXidative Stress
Pharmacy Web access Signature Log
INSTITUTION: SITE NUMBER: INVESTIGATOR: Please complete the Electronic Data Capture (EDC) System Access Signature Sheet for the most responsible Pharmacist/technician(s) at your site who will be checking the randomization or dispensing/checking study supplements. A signature and email address is required to create user accounts for the web based system for the REDOXS© Study.
NAME TITLE SIGNATURE EMAIL DATE
NOTE: By completing the information in the table above, the individual confirms they have been delegated the responsibility of checking the randomization and dispensing/verifying study supplements for the REDOXS© Study. The individual agrees to keep their password confidential to prevent unauthorized access to the data. Reference: ICH GCP 5.5.3
Pharmacy Log In Pharmacy Manual p 5
Pharmacy Treatment assignment
Note: this is not the randomization list that will be used for the study.
Pharmacy Manual p 6
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
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
Remove company label and staple to Form B
Attach pharmacy label to bottle
(maintain blinding)
Pharm Manual p 12, 13
Enteral Dispensing LogPharm Manual p 14
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 vialEU sites: dose is 10 mls (500 micrograms) = 1 vial
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
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, 32
Refer to Revised
Worksheets on web
Nov 2007
Appendix F: Height and Dose of
Dipeptiven
Pharm Manual p 36
Parenteral Worksheet: GLN
Use Revised
Worksheets (for >196 cms)
on web November 2007
Pharm Manual p 15, 31-41
Parenteral Worksheet: AOX
Use Revised
Worksheets (for >196 cms)
on web November 2007
Parenteral Worksheet: AOX+GLN
Use Revised
Worksheets (for >196 cms)
on web November 2007
Parenteral Worksheet: Placebo
Use Revised
Worksheets (for >196 cms)
on web November 2007
• Do NOT ignore overfill in Normal Saline bag
• Remove the volume of known overfill from normal saline bag
New change to Pharmacy Procedures: March 2009
Parenteral Label
Pharm Manual p 16, 42
Parenteral Study Supplement Log
Pharm Manual p 17
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
Nutrient Accountability LogsOne log for each product except
for normal saline
Pharm Manual p 19-25
Monthly Site Inventory Log
Fax in to CERU monthly
Pharm Manual p 8,9
EU sites: From Biosyn
US sites: Pharmacy stock vs. Baxter
Temperature Log
Fax similar log to CERU monthly
Pharm Manual p 10, 11
Delegation of Authority Log
Main pharmacist to sign this Delegation of Authority Log
Pharmacy Delegation Log
All pharmacy staff involved to sign
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 (blinded to Methods centre, unblinded on site)
4. Steps to prevent recurrence
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
REDOXS© Circular and Bulletin
Questions?? Imp Manual Tools
Resources available www.criticalcarenutrition.com >REDOXS