Critical Illness, ARDS, Septic Shock, Multiple Trauma, Seizure Disorder, Hemorrhagic Shock
Conditions
Keywords
Enteral nutrition, Intensive Care Units, caloric restriction, insulin, mortality, protein catabolism
Brief summary
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.
Detailed description
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
Interventions
DIETARY_SUPPLEMENTReplenish Protein
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.
DIETARY_SUPPLEMENTStandard protein
Subjects randomized to this group will receive 0.8 - 1 g of protein/kg/day for day 6-14
Sponsors
King Abdullah International Medical Research Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment | 6 months | Recruitment log |
| Retention rate | 14 days | withdrawals |
| Achieved protein intake | 14 days | Feeding data |
Countries
Saudi Arabia
Outcome results
None listed