NCT04475666 Replacing Protein Via Enteral Nutrition in Critically Ill Patients
| NCT ID | NCT04475666 |
| Status | Recruiting |
| Phase | — |
| Sponsor | King Abdullah International Medical Research Center |
| Condition | Critical Illness |
| Study Type | INTERVENTIONAL |
| Enrollment | 2,502 participants |
| Start Date | 2020-09-21 |
| Primary Completion | 2025-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 2,502 participants in total. It began in 2020-09-21 with a primary completion date of 2025-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Yaseen M Arabi, MD
PRINCIPAL INVESTIGATOR
King Saud Bin Abdulaziz University for Health Sciences
Frequently Asked Questions
Who can join the NCT04475666 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Critical Illness. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04475666 currently recruiting?
Yes, NCT04475666 is actively recruiting participants. Contact the research team at arabi@ngha.med.sa for enrollment information.
Where is the NCT04475666 trial being conducted?
This trial is being conducted at Jeddah, Saudi Arabia, Riyadh, Saudi Arabia.
Who is sponsoring the NCT04475666 clinical trial?
NCT04475666 is sponsored by King Abdullah International Medical Research Center. The principal investigator is Yaseen M Arabi, MD at King Saud Bin Abdulaziz University for Health Sciences. The trial plans to enroll 2,502 participants.