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

NCT07273071 | Not Yet Recruiting Phase 4 DMC

• 2 other identifiers: IMPACT-NAC-012026-525895-25-00
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Sepsis; Acute Infection; Severe Infection; Acetylcysteine; Liver dysfunction

Outcome Measures

Primary Outcomes (1)

• Days alive and out of hospital at 14 days post-randomization (DAOH-14)

  Assessed 14 days post-randomization

Secondary Outcomes (6)

• Number of participants with one or more serious adverse event within 14 days of randomization

  Assessed 14 days post-randomization

• All-cause mortality at day 180

  Assessed at 180 days post-randomization

• Health-related quality of life (HRQoL) at day 180 using EQ-5D-5L

  Assessed 180 days post-randomization

• Admission to an intensive care unit (ICU) within 14 days of admission

  Assessed at 14 days post-randomization

• Duration of antibiotic therapy from randomization to day 14

  Assessed at 14 days post-randomization

Study Arms (2)

N-acetylcysteine

EXPERIMENTAL

Drug: N-Acetylcysteine (NAC) Treatment

Placebo (normal saline)

NO INTERVENTION

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.

N-acetylcysteine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years
• Documented clinical suspicion of infection
• Model for end-stage liver disease (MELD) score ≥9

You may not qualify if:

• Admitted to hospital \>24 hours before randomization
• Any previous severe anaphylaxis
• Other known allergy to N-acetylcysteine
• Ongoing treatment with N-acetylcysteine at randomization
• Documented clinical suspicion of bile duct obstruction
• Refractory circulatory shock
• Informed consent not obtainable
• Inability to read and understand Danish to a degree that allows valid informed consent and completion of trial assessments
• Involuntary admission under the psychiatric law
• Expected initiation of palliative care within 48 hours of randomization
• Ongoing treatment with nitroglycerin
• Any other condition deemed by the investigator to compromise patient safety or trial integrity (e.g., severe coagulopathy, uncontrolled bleeding, diabetic ketoacidosis)

Sponsors & Collaborators

• Theis S. Itenov: lead
• University Hospital Bispebjerg and Frederiksberg: collaborator

Study Sites (1)

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

Copenhagen, 2400, Denmark

Location

MeSH Terms

Conditions

Sepsis; Infections; Liver Diseases

Interventions

Acetylcysteine; Therapeutics

Condition Hierarchy (Ancestors)

Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Central Study Contacts

Frans Wiberg, MD

CONTACT

+4528741294; frans.wiberg@regionh.dk

Theis S Itenov, MD, PhD

CONTACT

theis.skovsgaard.itenov@regionh.dk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Data Safety and Monitoring Board.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Associate Professor and Specialist Physician

Study Record Dates

• First Submitted: November 26, 2025
• First Posted: December 9, 2025
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): May 1, 2028
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

DK (1)