SepsisPhase 4IMPACT-NACNCT07273071
Individualized Multiplex Pathophysiological Treatment of Severe Acute Infections: N-Acetylcysteine
A Phase 4 study testing N-Acetylcysteine (NAC) Treatment in people with Sepsis and Acute Infection, run by Theis S. Itenov at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Acute Infection, Severe Infection
- What is being tested?
- N-Acetylcysteine (NAC) Treatment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteDenmark
- Study dates
- 7 Sep 2026to Jul 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Documented clinical suspicion of infection
- Model for end-stage liver disease (MELD) score ≥9
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Theis S Itenov, MD, PhD contact
Denmark1 site, 1 recruiting
- Recruiting
Department of Emergency Medicine, Copenhagen University Hospital - Bispebjerg and Frederiksberg
Copenhagen, 2400
Frans Wiberg, MD, +4523704894, frans.wiberg@regionh.dk
Jens H Rasmussen, MD
About this study
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
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?
Read more
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
- Being tested
- N-Acetylcysteine (NAC) Treatment
- Keywords
- Sepsis, Acute Infection, Severe Infection, Acetylcysteine, Liver dysfunction
- Medical subject headings
- Sepsis, Infections, Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-Acetylcysteine (NAC) TreatmentDrug
Intravenous infusion of N-acetylcysteine (200 mg/kg mixed with normal saline to a final volume of 500 ml) administered over four hours.
| Study group | Role | What they receive |
|---|---|---|
| N-acetylcysteine | Experimental | Not described Receives: Drug: N-Acetylcysteine (NAC) Treatment |
| Placebo (normal saline) | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Days alive and out of hospital at 14 days post-randomization (DAOH-14)
Measured: Assessed 14 days post-randomization
Secondary outcomes (6)
Number of participants with one or more serious adverse event within 14 days of randomization
Measured: Assessed 14 days post-randomization
All-cause mortality at day 180
Measured: Assessed at 180 days post-randomization
Health-related quality of life (HRQoL) at day 180 using EQ-5D-5L
Measured: Assessed 180 days post-randomization
Admission to an intensive care unit (ICU) within 14 days of admission
Measured: Assessed at 14 days post-randomization
Duration of antibiotic therapy from randomization to day 14
Measured: Assessed at 14 days post-randomization
Time to clinical stability
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.
Measured: Assessed at 14 days post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start7 Sep 2026
- Primary completionFeb 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Theis S. Itenov
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Bispebjerg and Frederiksberg
- Responsible party
- Sponsor-investigator, Theis S. Itenov, University Hospital Bispebjerg and Frederiksberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07273071
- Sponsor's protocol ID
- IMPACT-NAC-01
- Other IDs
- 2026-525895-25-00
- Acronym
- IMPACT-NAC
- Status last verified
- Sep 2026
- First submitted
- 26 Nov 2025
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07273071
- Acronym / sponsor ID
- IMPACT-NAC / IMPACT-NAC-01
- Conditions
- Sepsis, Acute Infection, Severe Infection
- Keywords
- Sepsis, Acute Infection, Severe Infection, Acetylcysteine, Liver dysfunction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Theis S. ItenovUniversity, hospital or other
- Collaborators
- University Hospital Bispebjerg and Frederiksberg
- Study start
- 7 Sep 2026 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 9 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| N-acetylcysteine | Experimental | Drug: N-Acetylcysteine (NAC) Treatment |
| Placebo (normal saline) | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥18 years
- Documented clinical suspicion of infection
- Model for end-stage liver disease (MELD) score ≥9
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| N-Acetylcysteine (NAC) TreatmentIntravenous infusion of N-acetylcysteine (200 mg/kg mixed with normal saline to a final volume of 500 ml) administered over four hours. | Drug | N-acetylcysteine |
Primary outcome
Days alive and out of hospital at 14 days post-randomization (DAOH-14)
Time frame: Assessed 14 days post-randomization
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Theis S Itenov, MD, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing N-Acetylcysteine (NAC) Treatment in people with Sepsis and Acute Infection, run by Theis S. Itenov at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Frans Wiberg, MD (+4528741294, frans.wiberg@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Days alive and out of hospital at 14 days post-randomization (DAOH-14) (time frame: Assessed 14 days post-randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.