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Search / Trial NCT04475666

Replacing Protein Via Enteral Nutrition in Critically Ill Patients

Launched by KING ABDULLAH INTERNATIONAL MEDICAL RESEARCH CENTER · Jul 14, 2020

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying the effects of adding extra protein to the diets of critically ill patients who are receiving nutrition through feeding tubes. The researchers want to see if providing a higher amount of protein (2-2.4 grams per kilogram of body weight per day) from day 5 in the ICU until the patient is discharged can improve survival rates compared to those receiving a moderate amount of protein (0.8-1.2 grams per kilogram per day). The trial aims to determine if this nutritional support can impact overall health and reduce the risk of death over a period of 90 days.

To participate in this study, patients must be at least 18 years old and currently receiving enteral nutrition through a feeding tube while on invasive mechanical ventilation. They should also be expected to stay in the ICU for at least another day. Those who are pregnant, have certain severe liver conditions, or are receiving other forms of nutrition are not eligible. If patients agree to participate, they will receive either the additional protein or the standard nutrition and will be monitored closely during their stay in the ICU. This trial is currently recruiting participants, and it is important for families to discuss any questions or concerns with their loved one's healthcare team.

Gender

ALL

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

About King Abdullah International Medical Research Center

The King Abdullah International Medical Research Center (KAIMRC) is a leading institution dedicated to advancing healthcare through innovative research and clinical trials. Established to support and enhance medical research in alignment with the Kingdom of Saudi Arabia's Vision 2030, KAIMRC focuses on a wide range of health issues, aiming to improve patient outcomes and foster scientific collaboration. With a commitment to ethical standards and rigorous methodologies, KAIMRC facilitates the translation of research findings into clinical practice, making significant contributions to the global medical community.

Locations

Riyadh,, , Saudi Arabia

Jeddah, , Saudi Arabia

Patients applied

0 patients applied

Trial Officials

Yaseen M Arabi, MD

Principal Investigator

King Saud Bin Abdulaziz University for Health Sciences

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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