Individualized Multiplex Pathophysiological Treatment of Severe Acute Infections: N-Acetylcysteine (IMPACT-NAC)

Theis S. Itenov

Status and phase: Begins enrollment in 2 months; Phase 4

Conditions: Acute Infection; Severe Infection; Sepsis

Treatments: Drug: N-Acetylcysteine (NAC) Treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT07273071

IMPACT-NAC-01

2026-525895-25-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

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.

Enrollment: 360 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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360 participants in 2 patient groups

N-acetylcysteine

Experimental group

Treatment:

Drug: N-Acetylcysteine (NAC) Treatment

Placebo (normal saline)

No Intervention group