Status:
COMPLETED
Replacing Protein Via Enteral Nutrition in a Stepwise Approach in Critically Ill Patients
Lead Sponsor:
King Abdullah International Medical Research Center
Conditions:
Critical Illness
ARDS
Eligibility:
All Genders
18+ years
Phase:
NA
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 r...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Age ≥ 18 years
- Mechanically ventilated
- Receiving enteral feeding via nasogastric/orogastric or duodenal or PEG or jejunostomy tubes and
- Expected to stay ≥ 1 week in the ICU
- Exclusion criteria
- 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).
- 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;
- New onset renal replacement therapy.
- Acute Kidney Injury (serum creatinine \> 3 times the preacute level or serum creatinine \>350mmol/L with a recent increase of \>44 mmols/L)
- Significant liver impairment
Exclusion
Key Trial Info
Start Date :
May 16 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 10 2019
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03480555
Start Date
May 16 2018
End Date
September 10 2019
Last Update
January 5 2021
Active Locations (2)
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1
King Abdulaziz Medical city
Jeddah, Saudi Arabia, 21423
2
King Abdulaziz Medical city
Riyadh, Saudi Arabia, 11426