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

Sponsor
Theis S. Itenov
Study ID
NCT07273071
Phase
PHASE4
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Acute Infection
  • Sepsis
  • Severe Infection

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Dec 9, 2025
Start date
Jul 31, 2026
Status verified
Mar 2026
Primary completion
Dec 31, 2027
Completion
May 31, 2028

Study Design

Enrollment
360 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: N-acetylcysteine
  • No Intervention: Placebo (normal saline)

Primary Outcome Measure

Days alive and out of hospital at 14 days post-randomization (DAOH-14) [ Time Frame: Assessed 14 days post-randomization ]

Central Contacts

Related Studies