NCT07273071

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

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

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 360 (estimated)
• Sponsor: Theis S. Itenov · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Sepsis
• Acute Infection
• Severe Infection

Interventions

Type	Name	Description
DRUG	N-Acetylcysteine (NAC) Treatment	Intravenous infusion of N-acetylcysteine (200 mg/kg mixed with normal saline to a final volume of 500 ml) administered over four hours.

Timeline

• Start date: 2026-07-01
• Primary completion: 2027-12-01
• Completion: 2028-05-01
• First posted: 2025-12-09
• Last updated: 2026-03-27

Locations

1 site across 1 country: Denmark