Increasing protein intake for critically ill patients in the ICU

Replacing Protein Via Enteral Nutrition in a Stepwise Approach in Critically Ill Patients: An International, Multicenter Randomized Controlled Trial

This study tests if giving more protein to critically ill patients in the ICU can help them survive longer compared to those who get the usual amount.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 2502 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: King Abdullah International Medical Research Center (Academic / other)
• Locations: 2 sites (Jeddah, Jeddah and 1 other locations)
• Trial ID: NCT04475666 on ClinicalTrials.gov

What this trial studies

This trial investigates the effects of supplemental enteral protein on critically ill patients in the ICU. Patients will be randomized to receive either a standard protein intake or an increased protein intake starting from ICU day 4 until discharge or up to 90 days. The study aims to compare the all-cause 90-day mortality rates between the two groups. The trial is multicentric and open-label, focusing on patients who are on invasive mechanical ventilation and have specific nutritional needs.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who are receiving enteral nutrition and are on invasive mechanical ventilation in the ICU.

Not a fit: Patients who are not on life support, those receiving parenteral nutrition, or those who have already exceeded the protein intake threshold in the first four ICU days may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve survival rates for critically ill patients by ensuring they receive adequate protein nutrition.

How similar studies have performed: Other studies have shown that optimizing protein intake in critically ill patients can lead to improved outcomes, suggesting that this approach may be beneficial.

Eligibility criteria

Inclusion Criteria(on ICU calendar day 4 or the morning of day 5)

1. Age ≥18-years old
2. Patient started on enteral nutrition (EN) via nasogastric/orogastric or duodenal or percutaneous endoscopic gastrostomy (PEG) or jejunostomy tubes.
3. The patient is on invasive mechanical ventilation and unlikely to be discharged from ICU next day.

Exclusion Criteria:

1. 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.
2. 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.
3. Patients who received an average protein of more than 0.8g/kg/day in the first 4 ICU days.
4. Patients being fed entirely through oral route - i.e. those who are eating.
5. Pregnancy.
6. Burn patients.
7. Prisoners or those undergoing forced treatment.
8. Patients with hepatic encephalopathy or Child C liver cirrhosis
9. Inherited defect of amino acid metabolism.
10. Allergies to protein supplement

Where this trial is running

Jeddah, Jeddah and 1 other locations

• King Abdulaziz Medical city — Jeddah, Jeddah, Saudi Arabia (Recruiting)
• Intensive Care Unit, King Abdulaziz Medical City — Riyadh, Saudi Arabia (Recruiting)

Study contacts

• Principal investigator: Yaseen M Arabi, MD — King Saud Bin Abdulaziz University for Health Sciences
• Study coordinator: Yaseen M Arabi, MD

Conditions Critical Illness; Nutrition Disorders