Acetylcysteine for Adults with Acute Infection or Sepsis and Liver Dysfunction

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What is this study about?

This clinical trial is studying adults with acute infection or sepsis who also have signs of liver dysfunction, which means the liver is not working properly. The treatment being tested is N-acetylcysteine, also called acetylcysteine, given as an intravenous infusion into a vein. The study is being done to see whether this treatment can improve recovery and reduce time spent in the hospital.

People in the study are assigned by chance to receive either acetylcysteine or sodium chloride. The treatment is given during the hospital stay, and the study then follows the course of recovery over the next days and months. The study looks at how well participants do after treatment, including survival and length of hospital stay, without using complicated procedures in the description.

Sepsis is a serious reaction to infection that can quickly become life-threatening. Liver dysfunction means the liver is injured or not working normally. The purpose of this study is to assess whether acetylcysteine can help adults with severe infection and liver dysfunction recover better.

1 randomization and first infusion

After joining the study, you are assigned by chance to one of two treatment groups. This assignment is called randomization, which means the treatment group is chosen randomly.

If you are placed in the active treatment group, you receive acetylcysteine by intravenous infusion (medicine given through a vein) at a dose of 200 mg/kg.

If you are placed in the comparison group, you receive sodium chloride by intravenous infusion at a dose of 500 ml. Sodium chloride is a salt solution used here as a placebo, which means it does not contain the study medicine.

The trial is blinded, which means that the treatment assignment is kept hidden during the study.

2 treatment period through day 14

Your treatment is followed from the time of randomization until day 14.

During this period, the study records how many days you are alive and out of the hospital.

The study also records whether you have one or more serious adverse events within 14 days. A serious adverse event is a harmful medical problem that is severe.

The study records whether you are admitted to an ICU within 14 days. ICU means intensive care unit, a hospital area for very close monitoring and treatment.

The study records the duration of antibiotic therapy from randomization to day 14. Antibiotics are medicines used to treat infections.

The study records the time to clinical stability, which means the time until your condition becomes medically stable.

3 follow-up to day 180

Your progress is followed until day 180 after randomization.

The study records all-cause mortality at day 180, which means whether you have died from any cause by that time.

The study records health-related quality of life at day 180 using the EQ-5D-5L index values. EQ-5D-5L is a questionnaire that measures general health and daily well-being.

The study records how many days you are alive and out of the hospital from randomization to day 180.

Who Can Join the Study?

Be 18 years of age or older.
Have a documented clinical suspicion of infection, meaning the medical team has recorded that an infection is likely based on the patient’s symptoms, examination, or test results.
Have a MELD score of 9 or higher. The MELD score is a medical score used to measure how well the liver is working; a higher score means more liver dysfunction.

Who Cannot Join the Study?

Being admitted to the hospital for more than 24 hours before being assigned to the study.
Having a documented or strongly suspected bile duct obstruction, which means a blockage in the tubes that carry bile from the liver.
Having refractory circulatory shock, meaning a very severe drop in blood flow that does not improve with treatment.
Being unable to give informed consent, which means being unable to understand the study well enough and agree to take part.
Being pregnant.
Being unable to read and understand Danish well enough to give valid consent and complete the study tests.
Being admitted against the person’s will under psychiatric law, meaning compulsory psychiatric admission.
Having any other condition that the study doctor thinks could affect safety or the reliability of the study results, such as:
- Severe coagulopathy, meaning a serious problem with blood clotting.
- Uncontrolled bleeding.
- Diabetic ketoacidosis, a dangerous complication of diabetes caused by very high blood acidity.
Expected to start palliative care within 48 hours after being assigned to the study, meaning care focused on comfort rather than recovery.
Already receiving nitroglycerin, a medicine often used for chest pain and heart problems.
Having had any previous severe anaphylaxis, which means a very serious allergic reaction.
Having a known allergy to N-acetylcysteine.
Already being treated with N-acetylcysteine at the time of study assignment.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Roskilde University	Roskilde	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Not yet recruiting	01.07.2026

Trial locations

Investigated drugs:

Acetylcysteine is the active treatment being tested in this trial. It is given through a vein and is being studied in adults with acute infection or sepsis who also have signs of liver problems. The trial is looking to see whether it can help lower the risk of death and shorten the time spent in the hospital.

Investigated diseases:

Acute Infection – An acute infection is a sudden infection caused by bacteria, viruses, fungi, or other germs that develops quickly over a short period. It usually begins with a rapid increase in symptoms such as fever, pain, swelling, or weakness, depending on the body part involved. The illness often progresses over hours to days and may remain limited to one area or spread to other parts of the body if it becomes more severe.

Sepsis – Sepsis is a serious body-wide response to an infection in which the immune system reacts in an abnormal and overwhelming way. It usually develops from an infection that starts in one place and then triggers widespread inflammation throughout the body. As it progresses, it can cause worsening weakness, confusion, breathing problems, and problems with blood flow and organ function.

Trial ID:

2026-525895-25-00

Trial Phase:

Therapeutic confirmatory (Phase III)

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Acetylcysteine for Adults with Acute Infection or Sepsis and Liver Dysfunction

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?