Increasing protein intake for critically ill patients in the ICU

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: arabi@ngha.med.sa
• Phone: 0118011111

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.