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Not yet recruiting NCT07273071

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

Phase IV Interventional Sepsis Acute Infection Severe Infection

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: N-Acetylcysteine (NAC) Treatment.
Who it may be relevant to
Registry conditions: Sepsis, Acute Infection, Severe Infection. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Days alive and out of hospital at 14 days post-randomization (DAOH-14) [Time frame: Assessed 14 days post-randomization]
Secondary outcome measures (6)
  • Number of participants with one or more serious adverse event within 14 days of randomization [Time frame: Assessed 14 days post-randomization]
  • All-cause mortality at day 180 [Time frame: Assessed at 180 days post-randomization]
  • Health-related quality of life (HRQoL) at day 180 using EQ-5D-5L [Time frame: Assessed 180 days post-randomization]
  • Admission to an intensive care unit (ICU) within 14 days of admission [Time frame: Assessed at 14 days post-randomization]
  • Duration of antibiotic therapy from randomization to day 14 [Time frame: Assessed at 14 days post-randomization]
  • Time to clinical stability [Time frame: Assessed at 14 days post-randomization]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Denmark · 1 center
  • Department of Emergency Medicine, Copenhagen University Hospital - Bispebjerg and Frederik — Copenhagen

Identifiers

NCT: NCT07273071 · IMPACT-NAC-01 · 2026-525895-25-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗