Replacing Protein Via Enteral Nutrition in Critically Ill Patients
Replacing Protein Via Enteral Nutrition in a Stepwise Approach in Critically Ill Patients: An International, Multicenter Randomized Controlled Trial
King Abdullah International Medical Research Center
2,502 participants
Sep 21, 2020
INTERVENTIONAL
Conditions
Summary
The investigator will investigate the effect of supplemental enteral protein (1.2 g/kg/day) added to standard formula to achieve high amount of enteral protein (range 2-2.4 g/kg/day) given from ICU day 5 until ICU discharge up to ICU day 90 as compared to no supplemental enteral protein to achieve moderate amount enteral protein (0.8-1.2 g/kg/day), given in conjunction with similar amounts of stepwise caloric administration in the two groups on all-cause 90-day mortality.
Eligibility
Inclusion Criteria3
- Age ≥18-years old
- Patient started on enteral nutrition (EN) via nasogastric/orogastric or duodenal or percutaneous endoscopic gastrostomy (PEG) or jejunostomy tubes.
- The patient is on invasive mechanical ventilation and unlikely to be discharged from ICU next day.
Exclusion Criteria10
- Lack of commitment to full life support or brain death. Patients with "Do Not Resuscitate" order but with commitment to ongoing life support can be enrolled.
- Patients on any amount of parenteral nutrition (PN) in ICU at the time of screening, whether PN is used alone or in combination with enteral nutrition. Non-nutritional calories (dextrose, propofol, citrate) not considered as PN.
- Patients who received an average protein of more than 0.8g/kg/day in the first 4 ICU days.
- Patients being fed entirely through oral route - i.e. those who are eating.
- Pregnancy.
- Burn patients.
- Prisoners or those undergoing forced treatment.
- Patients with hepatic encephalopathy or Child C liver cirrhosis
- Inherited defect of amino acid metabolism.
- Allergies to protein supplement
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Interventions
For patients with Body mass index(BMI) \<30, use pre-ICU actual body weight(BW) for the calculation; if unavailable, use weight on ICU admission. For patients with BMI \>=30, use adjusted body weight
For patients with BMI \<30, use pre-ICU actual BW for the calculation; if unavailable, use weight on ICU admission. For patients with BMI \>=30, use adjusted body weight
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04475666