Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
NCT04475666

Replacing Protein Via Enteral Nutrition in Critically Ill Patients

Led by King Abdullah International Medical Research Center · Updated on 2025-09-08

2502

Participants Needed

2

Research Sites

292 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Replacing Protein Via Enteral Nutrition in Critically Ill Patients

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years of age or older
  • Patient started on enteral nutrition via nasogastric, orogastric, duodenal, PEG, or jejunostomy tubes
  • Patient is on invasive mechanical ventilation and unlikely to be discharged from ICU the next day
Not Eligible

You will not qualify if you...

  • Lack of commitment to full life support or brain death; patients with Do Not Resuscitate orders but ongoing life support commitment can be enrolled
  • Receiving any parenteral nutrition in ICU at screening
  • Received average protein intake greater than 0.8 g/kg/day in the first 4 ICU days
  • Being fed entirely by mouth (eating)
  • Pregnancy
  • Burn patients
  • Prisoners or undergoing forced treatment
  • Hepatic encephalopathy or Child C liver cirrhosis
  • Inherited amino acid metabolism defects
  • Allergies to protein supplements

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

King Abdulaziz Medical city

Jeddah, Jeddah, Saudi Arabia, 21423

Actively Recruiting

2

Intensive Care Unit, King Abdulaziz Medical City

Riyadh, Saudi Arabia, 11426

Actively Recruiting

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Research Team

Y

Yaseen M Arabi, MD

CONTACT

M

Musharaf Sadat, MBBS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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