General information:
Over the past decade, there have been significant advances in our understanding of the role of nutrition in general, and key nutrients specifically, in the treatment of critically ill patients. Over 40 years ago, when artificial nutrition was developed, it was conceived of as supportive care, as administering metabolic support while the patient recovers from their underlying illness. Nutrition support teams were developed, malnourished and catabolic patients were identified, measurements and calculations were done, and artificial nutrition was provided to minimize the loss of protein, calories, and micronutrients associated with inflammatory conditions. During this era, very few large-scale trials informed practice patterns. It seemed that as long as the nutrition interventions ‘restored' deficient substrates or reduced the loss of expended substrates, it was provided to broad, heterogeneous groups of patients, with little regard for its effect on clinically important outcomes. Debates over energy requirements or protein loss dominated the discussion. Over the last decade, with the application of meta-analytic techniques, and larger randomized clinical trials, stronger signals of therapeutic effect have appeared. Our nutritional strategies appeared to be making an impact on patient outcomes as recently summarized in the form of clinical practice guidelines (i). What was most illuminating from this review process was that the largest treatment effects on clinically important outcomes were from studies of specific nutrients, such as glutamine, antioxidants, fish oils, and arginine. Thus, the concept of pharmaconutrition emerged. Distinct from the historical concepts, this new treatment paradigm embraced the fact that nutrients (and some nutritional strategies) have profound effects on underlying inflammatory, immunological, metabolic, and other pathophysiological processes of critically ill patients. The focus was on understanding the influence of these nutrients on the underlying disease process and subsequent clinical outcomes, and less about nitrogen balance or energy requirements. We have moved from supporting patients while they recover from their underlying illness to modulating that disease response and improving the chances of survival.
Listen to the Podcast of Dr. Daren Heyland on Pharmaconutrition here, presented by the Society of Critical Care Medicine (SSCM)
Recently published reviews:
- Jones, N. E. Heyland, D. K. Pharmaconutrition: a new emerging paradigm. Current Opinion in Gastroenterology. 2008: 24: 215-222. Pubmed Abstract
- Wischmeyer, P. E. Glutamine: role in critical illness and ongoing clinical trials. Current Opinion in Gastroenterology. 2008: 24: 190-197. Pubmed Abstract
- Heyland DK, Jones N, Cvijanovich NZ, Wong H. Zinc supplementation in critically ill patients: a key pharmaconutrient? JPEN 2008 32(5):509 19. Pubmed Abstract
See the Presentations section for information on Pharmaconutrition.
See the CPGs for randomized controlled trials in pharmaconutrition.
The results of the REDOXS trial have been published in the New England Journal of Medicine. You may view the article here as well as an accompanying NIBBLE (Nutrition Information Byte), a 2-page concise summary of the impact of REDOXS on the future use of glutamine in critically ill patients. Following the publication of the MetaPlus trial, a second NIBBLE was written regarding glutamine supplementation.
A post-hoc analysis by Heyland et al was published in JPEN re-evaluating the effect of glutamine and antioxidant supplementation after controlling for baseline covariates. Results showed that early high doses of glutamine were not beneficial and may have been associated with increased mortality in the critically ill with multi-organ failure. The most harm was seen with both glutamine and antioxidant supplementation in the critically ill with a diagnosis of multi-organ failure including renal failure at time of study enrollment.
On behalf of Dr. Heyland, Rupinder Dhaliwal, Janet Overvelde and the Critical Care Nutrition and Clinical Evaluation Research Unit teams, we would like to thank all our participating sites and collaborators for their support over the years! Here are some important highlights of the research related to the REDOXS Study:
2004-2005 REDOXS Dose Escalating Study
2005-2006 REDOXS Pilot Study
2007-2012 REDOXS Multicentre Definitive Study: 5 countries participated and 45 sites screened 5639 patients to recruit 1223 patients and collect 355,893 pieces of data!
The REDOXS© Circular provides invaluable updates on enrollment, data entry, regulatory and pharmacy issues, reminders and Frequently Asked Questions. The REDOXS© Bulletin provides in-depth coverage of current issues of interest.
Frequently Asked Questions featured in REDOXS© circular
Frequently Asked Questions
REDOXS© Circular
- Issue #1 : June 2007
- Issue #2 : July 2007
- Issue #3 : September 2007
- Issue #4 : November 2007
- Issue #5 : December 2007
- Issue #6 : January 2008
- Issue #7 : February 2008
- Issue #8 : March 2008
- Issue #9 : April 2008
- Issue #10: May 2008
- Issue #11: June 2008
- Issue #12: July 2008
- Issue #13: August 2008
- Issue #14: September 2008
- Issue #15: October 2008
- Issue #16: November 2008
- Issue #17: December 2008
- Issue #18: January 2009
- Issue #19: February 2009
- Issue #20: March 2009
- Issue #21: April 2009
- Issue #22: May 2009
- Issue #23: June 2009
- Issue #24: July 2009
- Issue #25: August 2009
- Issue #26: September 2009
- Issue #27: October 2009
- Issue #28: November 2009
- Issue #29: December 2009
- Issue #30: January 2010
- Issue #31: February 2010
- Issue #32: March 2010
- Issue #33: April 2010
- Issue #35: May 2010
- Issue #36: June 2010
- Issue #37: July 2010
- Issue #38: August 2010
- Issue #44: February 2011
REDOXS© Bulletin
The resources below have been provided for the sites actively participating in the REDOXS© Study. The information will be useful for Site Investigators, Research Coordinators, Dietitians, Pharmacists and Pharmacy Technicians.
[Right Click on the links: pdf or doc to Save the Target Document.]
Study Procedures Manual
Administration of Study Supplements | ||
Administration of Study Supplemens - EU version | ||
Implementation Manual | ||
Protocol Violations | ||
Serious Adverse Events*Sept 2008* | ||
SAE Initial Report Form | ||
SAE Follow-up Report Form | ||
Pharmacy Manual | ||
Pharmacy Manual - EU version | ||
Pharmacy Worksheets | doc | |
Pharmacy Worksheets - EU version | doc | |
Dietitian Manual | ||
Research Coordinator Worksheets | ||
Daily Monitoring Log | doc | |
SF36 | ||
English (Canadian) | ||
French (Canadian) | ||
Child's class C liver disease | ||
PF ratio table | ||
Unit conversion calculator | xls | |
Algorithm for elevated urea | ||
Lab Study Manual | ||
Conversion Table for FiO2 when on Mask or Nasal Cannula | ||
Annotated CRF |