Critical Illness Clinical Trial
— ReplenishOfficial title:
Replacing Protein Via Enteral Nutrition in a Stepwise Approach in Critically Ill Patients: Feasibility Randomized Controlled Trial
Verified date | December 2020 |
Source | King Abdullah International Medical Research Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
In this study, we will explore the feasibility of a randomized controlled trial that will compare high protein dose from ICU day 6 to 14 with moderate protein intake.
Status | Completed |
Enrollment | 40 |
Est. completion date | September 10, 2019 |
Est. primary completion date | May 10, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion criteria 1. Age = 18 years 2. Mechanically ventilated 3. Receiving enteral feeding via nasogastric/orogastric or duodenal or PEG or jejunostomy tubes and 4. Expected to stay = 1 week in the ICU Exclusion criteria 1. Lack of commitment to ongoing life support, which includes; - Terminal Illness (Malignancy or irreversible condition with 6 month mortality > 50%) - DNR order in the first 48 hours and brain death within 48 hours of admission) (Don't include the presence of a "Do Not Resuscitate" order alone, if there is a commitment to ongoing life support). 2. Patients not fed within 48 hours of admission 3. Patients on total parenteral nutrition (TPN) 4. Patients being fed orally 5. Chronic renal failure 6. Chronic liver disease 7. Renal replacement therapy 8. Pregnancy. 9. Kidney transplant 10. Post-liver transplant. 11. Post cardiac arrest. 12. Burn patients. 13. Prisoners Screened patients will be screened again for eligibility at day 5, should be mechanically ventilated and expected to stay = 3 days in the ICU. At this point, patients will be excluded if they meet the following; 1. New onset renal replacement therapy. 2. Acute Kidney Injury (serum creatinine > 3 times the preacute level or serum creatinine >350mmol/L with a recent increase of >44 mmols/L) 3. Significant liver impairment |
Country | Name | City | State |
---|---|---|---|
Saudi Arabia | King Abdulaziz Medical city | Jeddah | |
Saudi Arabia | King Abdulaziz Medical city | Riyadh |
Lead Sponsor | Collaborator |
---|---|
King Abdullah International Medical Research Center |
Saudi Arabia,
Arabi YM, Aldawood AS, Solaiman O. Permissive Underfeeding or Standard Enteral Feeding in Critical Illness. N Engl J Med. 2015 Sep 17;373(12):1175-6. doi: 10.1056/NEJMc1509259. — View Citation
Arabi YM, Casaer MP, Chapman M, Heyland DK, Ichai C, Marik PE, Martindale RG, McClave SA, Preiser JC, Reignier J, Rice TW, Van den Berghe G, van Zanten ARH, Weijs PJM. The intensive care medicine research agenda in nutrition and metabolism. Intensive Care — View Citation
McClave SA, Taylor BE, Martindale RG, Warren MM, Johnson DR, Braunschweig C, McCarthy MS, Davanos E, Rice TW, Cresci GA, Gervasio JM, Sacks GS, Roberts PR, Compher C; Society of Critical Care Medicine; American Society for Parenteral and Enteral Nutrition — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Recruitment | Recruitment log | 6 months | |
Primary | Retention rate | withdrawals | 14 days | |
Primary | Achieved protein intake | Feeding data | 14 days |
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