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Fasting in the ICU: a metabolic key to immune response?

NCT ID NCT07738536

Knowledge-focused Sponsor: Karolinska University Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 31, 2026 · Last updated Sep 02, 2026 · Updated 2 times

Summary

This study investigates what happens when critically ill patients in the intensive care unit (ICU) are not given nutrition for the first 72 hours after admission. Researchers will measure ketone bodies in the blood and examine how immune cells respond, comparing these patients to those receiving standard care. The goal is to understand whether short-term fasting induces ketosis and alters immune function in critical illness, which could inform future nutrition strategies in the ICU.

What this could mean

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

Active substance
Delayed nutrition (withholding enteral/parenteral nutrition and glucose solutions for the first 72 hours in the ICU)
What this could lead to
If this trial succeeds, it could reveal whether short-term fasting in critically ill patients is safe and beneficial, potentially guiding ICU nutrition practices to improve recovery.
What could go wrong
This is an early-stage substudy focused on biological markers, not clinical outcomes. Results may not translate to better patient outcomes, and fasting could pose risks in some critically ill 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 200 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Jul 2027

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: 1. Adult (≥18 years). 2. ICU admission (index admission to the participating ICU). Exclusion Criteria: 1. The patient requires intravenous glucose infusion, enteral nutrition or parenteral nutrition according to the attending clinician's assessment, 2. Acute or acute-on-chronic liver failure 3. Moderate hypernatremia ( \>150 mmol/L) 4. Diabetic ketoacidosis or hyperosmolar hyperglycemic state at admission, 5. Pregnancy, 6. Exclusive end-of-life care (no other treatment goal than comfort care for end of life), 7. Organ donor, 8. Prior enrolment in this trial during the same hospitalisation, 9. Patients with a metabolic disease requiring specific diet and patients with clinical need for a ketogenic diet. 10. Patients already enrolled in other interventional studies on nutrition, intravenous fluids, phosphate supplementation or hormonal therapies that influence glucose homeostasis. 11. Inclusion not possible due to site-specific regulatory issues regarding the ethical approval or informed consent procedure.

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Conditions

The condition(s) this trial relates to.

Critical Illness Fasting Ketosis nutritional disorder

As listed by the trial registrant

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

Critical illness Fasting state Ketosis Nutrition

How to take part

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  1. The places running it

    1 site. 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

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Contacts and locations

Locations

  • Karolinska University Hospital Huddinge

    Stockholm, 14186, Sweden

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