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Can extra protein save lives in the ICU?

NCT ID NCT04475666

Disease control Sponsor: King Abdullah International Medical Research Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tests whether giving extra protein through feeding tubes to critically ill patients on ventilators can lower the chance of death within 90 days. About 2,500 adults in ICUs will get either a high-protein or standard-protein diet starting day 5. The goal is to see if more protein helps patients survive and leave the hospital sooner.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
enteral protein supplement
What this could lead to
If it works, this could show that giving more protein to critically ill patients helps them survive and recover faster.
What could go wrong
This is a large trial, but nutrition interventions often show modest effects. The results may not apply to all ICU patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 2,502 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2020

Expected to finish

Apr 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Critical Illness nutritional disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Critical illness Nutrition disorders

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Intensive Care Unit, King Abdulaziz Medical City

    RECRUITING

    Riyadh, 11426, Saudi Arabia

  • King Abdulaziz Medical city

    RECRUITING

    Jeddah, Jeddah, 21423, Saudi Arabia

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