N-acetylcysteine for severe infection with liver dysfunction in adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, double-blind, placebo-controlled trial assigns 360 adults with suspected infection and a MELD score of 9 or higher to receive either N-acetylcysteine infusion or placebo within the first hospital day. The primary goal is to see if NAC increases days alive and out of hospital in the first 14 days after enrollment. Treatment is given as a four-hour IV infusion on day one, with outcomes including survival and length of stay. The study aims to tailor therapy to severe infections with liver dysfunction while monitoring safety in a high-risk population.

Why it matters

Who can join: the full rules

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)

Where it's running

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

Study contacts

• Study coordinator: Frans Wiberg, MD
• Email: frans.wiberg@regionh.dk
• Phone: +4528741294

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.