AuthorisedTherapeutic use (Phase IV)Interventional

A randomized, placebo-controlled, blinded, parallel-group clinical trial to assess the efficacy of N-acetylcysteine in adults with acute infections or sepsis and evidence of liver dysfunction: the IMPACT-NAC trial

This research, called the IMPACT-NAC trial, is investigating a medicine called N-acetylcysteine. It's for adults who have severe infections or a serious condition called sepsis, especially if their liver isn't working as well as it should. The main goal is to see if this medicine helps people get better faster and spend more time recovering at home, rather than in the hospital, during the first two weeks of their illness. Researchers will compare it to a dummy treatment (placebo) to understand its effects. This study is in its final phase, meaning the medicine has already been through earlier safety checks.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Region Hovedstaden

Enrolment target

360

Start

22 May 2026

Acute infection Sepsis

What is this study about?

Imagine you or someone you know gets a very bad infection, so severe that it might affect organs like the liver. Doctors are always looking for better ways to help people recover more quickly and stay out of the hospital.

This particular study, called the IMPACT-NAC trial, is looking at a medicine called N-acetylcysteine. N-acetylcysteine is already used for some medical conditions, and researchers want to find out if it can also help adults who have severe infections, or a life-threatening condition called sepsis, especially if their liver isn't working as well as it should. They are hoping it might help people get better and be discharged from hospital sooner.

To see if the medicine works, some people will receive N-acetylcysteine, while others will receive a 'dummy' treatment (a placebo) that looks the same but contains no active medicine. This helps the researchers accurately tell if any changes are due to the medicine itself. Everyone involved in the study – patients, doctors, and nurses – won't know who is getting which treatment until after the study is finished. This helps make sure the results are fair and unbiased. The main thing they'll be looking at is how many days people are alive and out of hospital in the first two weeks.

Key takeaways

The study investigates N-acetylcysteine for severe infections/sepsis with liver problems.
It aims to see if the medicine helps people recover faster and stay out of hospital.
Participants will receive either the active medicine or a matching dummy treatment (placebo).
Doctors and patients won't know who receives which treatment until the study ends.
The main focus is on 'days alive and out of hospital' in the first 14 days.
You can withdraw from the study at any time without affecting your care.

Who may be eligible?

This study is for adults who are at least 18 years old. Both men and women can take part.

You might be able to join if you have a severe infection or a condition called sepsis. The doctors involved in the study will also need to see signs that your liver isn't working quite right at the time of your illness.

Quick self-check

Are you 18 years old or older?
Do you currently have a severe infection or sepsis?
Has a doctor told you that your liver isn't working normally right now?
Are you able to provide consent (agree) to participate?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, you would be given either the study medicine (N-acetylcysteine) or a dummy treatment (placebo) through a drip. The researchers would carefully monitor your health and recovery while you are in the hospital. They would keep track of things like how long you need antibiotics and if you need to go to intensive care.

After you leave the hospital, there would be follow-up checks. The main goal is to see how many days you are alive and out of hospital in the first 14 days. They would also check in on you again about six months later (180 days) to see how you're feeling and how your overall health and quality of life are.

Potential risks and benefits

Taking part in any study has potential benefits and risks. You might benefit from the study medicine if it proves to be effective. However, there's also a chance you could receive the dummy treatment or that the medicine might not help your condition, or could even cause side effects, though serious effects are carefully monitored. Your safety and well-being are the top priority. You are always free to decide to stop taking part in the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

—
Denmark

Common questions

What is sepsis?

Sepsis is a life-threatening reaction to an infection where your body attacks its own tissues and organs. It's a medical emergency.

What is N-acetylcysteine?

N-acetylcysteine is a medicine that's already used for some health problems. Researchers are testing if it can help with severe infections and liver issues in this study.

What does 'placebo-controlled' mean?

It means some people get the study medicine, and others get a 'dummy' treatment that looks the same but has no medicine in it. This helps doctors see if the real medicine is actually working.

Will I know if I'm getting the medicine or the placebo?

No, neither you nor your doctors will know until after the study is over. This is called 'blinded' and helps keep the results fair.

How long will the study last for me?

The main part of monitoring will be during your hospital stay and for 14 days after joining. There will also be a check-up around 180 days (about 6 months) later.