Individualized Multiplex Pathophysiological Treatment of Severe Acute Infections: N-Acetylcysteine

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorTheis S. Itenov

About this trial

The primary objective of the IMPACT-NAC trial is to assess the effects of N-acetylcysteine on survival and hospital length of stay in adults admitted to the emergency department with acute infection or sepsis and evidence of liver dysfunction.

The main question it aims to answer is: does N-acetylcysteine increase the number of days alive and out of the hospital within the first 14 days after enrolment in the trial?

To answer this question, we will conduct a randomized, double-blinded controlled trial of 360 participants.

Participants will be randomized to either N-acetylcysteine or placebo (normal saline without active drugs). This will be administered as an infusion during four hours within the first day of hospital admission.

Eligibility criteria

Qualifiers

Age ≥18 years

Documented clinical suspicion of infection

Model for end-stage liver disease (MELD) score ≥9

Disqualifiers

Admitted to hospital >24 hours before randomization

Any previous severe anaphylaxis

Other known allergy to N-acetylcysteine

Ongoing treatment with N-acetylcysteine at randomization

Trial design

Treatments tested in this trial

  • N-Acetylcysteine (NAC) Treatment

Treatment groups

360 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Theis S. Itenov

Lead sponsor

University Hospital Bispebjerg and Frederiksberg

Sponsor institution

University Hospital Bispebjerg and Frederiksberg

Collaborator