NCT07273071 Individualized Multiplex Pathophysiological Treatment of Severe Acute Infections: N-Acetylcysteine
| NCT ID | NCT07273071 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Theis S. Itenov |
| Condition | Sepsis |
| Study Type | INTERVENTIONAL |
| Enrollment | 360 participants |
| Start Date | 2026-09-07 |
| Primary Completion | 2028-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 360 participants in total. It began in 2026-09-07 with a primary completion date of 2028-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07273071 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Sepsis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07273071 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07273071 currently recruiting?
Yes, NCT07273071 is actively recruiting participants. Contact the research team at frans.wiberg@regionh.dk for enrollment information.
Where is the NCT07273071 trial being conducted?
This trial is being conducted at Copenhagen, Denmark.
Who is sponsoring the NCT07273071 clinical trial?
NCT07273071 is sponsored by Theis S. Itenov. The trial plans to enroll 360 participants.