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NCT Number: NCT07273071

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

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.

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Key information

Conditions

Sepsis Acute Infection Digestive System Diseases Infections Inflammation Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Severe Infection Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Copenhagen, 2400, Denmark

Location contact

Jens H Rasmussen, MD

CONTACT

[email protected]

+4526198801

Jens H Rasmussen, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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)

Treatment and study plan

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.

Primary outcomes

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

    Time frame: Assessed 14 days post-randomization

Secondary outcomes

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

    Time frame: Assessed 14 days post-randomization

  2. All-cause mortality at day 180

    Time frame: Assessed at 180 days post-randomization

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

    Time frame: Assessed 180 days post-randomization

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

    Time frame: Assessed at 14 days post-randomization

  5. Duration of antibiotic therapy from randomization to day 14

    Time frame: Assessed at 14 days post-randomization

  6. Time to clinical stability

    Time frame: Assessed at 14 days post-randomization

    Number of days from randomization to first occurrence of clinical early warning score (C-EWS) ≤1. For participants with registered chronic elevated C-EWS parameters, the adjusted score will be used.

Study contacts

Contact information is provided by the study sponsor or research team.

Frans Wiberg, MD

CONTACT

[email protected]

+4528741294

Theis S Itenov, MD, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Theis S. Itenov

Other

Collaborators

  • University Hospital Bispebjerg and Frederiksberg

Registry information

Official study title

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

Acronym: IMPACT-NAC

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Dec 9, 2025
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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