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Could a common antioxidant help sepsis patients with liver damage?

NCT ID NCT07273071

Disease control Sponsor: Theis S. Itenov 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 17, 2026 · Updated 3 times

Summary

This study tests whether a single dose of N-acetylcysteine (NAC), an antioxidant, can help adults with severe infections and liver dysfunction recover faster. 360 participants will receive either NAC or a placebo infusion within 24 hours of hospital admission. The main goal is to see if NAC increases the number of days patients are alive and out of the hospital within the first two weeks.

What this could mean

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

Active substance
N-acetylcysteine (NAC)
What this could lead to
If it works, this could provide a simple, widely available treatment to improve survival and shorten hospital stays for sepsis patients with liver issues.
What could go wrong
This is a relatively small, early-stage trial (360 participants) testing a short-term infusion. The drug may not improve outcomes and could cause allergic reactions or other side effects.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 360 people

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

Started

Sep 2026

Expected to finish

Jul 2028

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

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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. Age ≥18 years 2. Documented clinical suspicion of infection 3. Model for end-stage liver disease (MELD) score ≥9 Exclusion criteria 1. Admitted to hospital \>24 hours before randomization 2. Any previous severe anaphylaxis 3. Other known allergy to N-acetylcysteine 4. Ongoing treatment with N-acetylcysteine at randomization 5. Documented clinical suspicion of bile duct obstruction 6. Refractory circulatory shock 7. Informed consent not obtainable 8. Inability to read and understand Danish to a degree that allows valid informed consent and completion of trial assessments 9. Involuntary admission under the psychiatric law 10. Expected initiation of palliative care within 48 hours of randomization 11. Ongoing treatment with nitroglycerin 12. Any other condition deemed by the investigator to compromise patient safety or trial integrity (e.g., severe coagulopathy, uncontrolled bleeding, diabetic ketoacidosis)

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Conditions

The condition(s) this trial relates to.

Infections infectious disease infectious disease with sepsis liver disorder Sepsis

As listed by the trial registrant

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

Acute infection Sepsis Severe infection

How to take part

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

  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

    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

  • Department of Emergency Medicine, Copenhagen University Hospital - Bispebjerg and Frederiksberg

    RECRUITING

    Copenhagen, 2400, Denmark

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