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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.
Patients will be recruited on day 1-2 of ICU admission. On day 5, patients will be randomized into one of the two intervention arms;
Replenish Protein group:
Patients randomized to this group will receive 2 g of protein/kg/day (acceptable range 1.8 - 2.2 g of protein/kg/day) for day 6-14.
Standard Protein group:
Patients randomized to this group will receive protein at 0.8 - 1.0 g of protein/kg/day for day 6-14
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Replenish Protein group | Active Comparator | Subjects randomized to this group will receive 2 g of protein/kg/day (acceptable range as 1.8 - 2.2 g of protein/kg/day) for day 6-14. |
|
| Standard Protein group | Other | Subjects randomized to this group will receive 0.8 - 1 g of protein/kg/day for day 6-14 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Replenish Protein | Dietary Supplement | Subjects randomized to this group will receive 2 g of protein/kg/day (acceptable range as 1.8 - 2.2 g of protein/kg/day) for day 6-14. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment | Recruitment log | 6 months |
| Retention rate | withdrawals | 14 days |
| Achieved protein intake | Feeding data | 14 days |
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Inclusion criteria
Exclusion criteria
Lack of commitment to ongoing life support, which includes;
Patients not fed within 48 hours of admission
Patients on total parenteral nutrition (TPN)
Patients being fed orally
Chronic renal failure
Chronic liver disease
Renal replacement therapy
Pregnancy.
Kidney transplant
Post-liver transplant.
Post cardiac arrest.
Burn patients.
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;
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| Name | Affiliation | Role |
|---|---|---|
| Yaseen M Arabi, MD | King Abdulaziz Medical City-Ministry of National Guard | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| King Abdulaziz Medical city | Jeddah | 21423 | Saudi Arabia | |||
| King Abdulaziz Medical city |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26773077 | Result | 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. Guidelines for the Provision and Assessment of Nutrition Support Therapy in the Adult Critically Ill Patient: Society of Critical Care Medicine (SCCM) and American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.). JPEN J Parenter Enteral Nutr. 2016 Feb;40(2):159-211. doi: 10.1177/0148607115621863. No abstract available. | |
| 26376142 |
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Data will be shared with the other participating sites after the completion of the main study and upon the descretion of the study Principle investigator only
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|
| Standard protein | Dietary Supplement | Subjects randomized to this group will receive 0.8 - 1 g of protein/kg/day for day 6-14 |
|
|
| Riyadh |
| 11426 |
| Saudi Arabia |
| Result |
| 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. No abstract available. |
| 28374096 | Result | 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 Med. 2017 Sep;43(9):1239-1256. doi: 10.1007/s00134-017-4711-6. Epub 2017 Apr 3. |
| 34330462 | Derived | Arabi YM, Al-Dorzi HM, Tamim H, Sadat M, Al-Hameed F, AlGhamdi A, Al Mekhlafi GA, Rasool G, Afesh L, Sakkijha MH, Alamrey NK, Malebari R, Alhutail RH, Al-Dawood A; Saudi Critical Care Trials Group. Replacing protein via enteral nutrition in a stepwise approach in critically ill patients: A pilot randomized controlled trial (REPLENISH pilot trial). Clin Nutr ESPEN. 2021 Aug;44:166-172. doi: 10.1016/j.clnesp.2021.05.008. Epub 2021 Jun 2. |
| ID | Term |
|---|---|
| D016638 | Critical Illness |
| D012772 | Shock, Septic |
| D009104 | Multiple Trauma |
| D004827 | Epilepsy |
| D012771 | Shock, Hemorrhagic |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D018805 | Sepsis |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D012769 | Shock |
| D014947 | Wounds and Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006470 | Hemorrhage |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
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