Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2026-525895-25-00 | EU Trial (CTIS) Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University Hospital Bispebjerg and Frederiksberg | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| N-acetylcysteine | Experimental |
| |
| Placebo (normal saline) | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Days alive and out of hospital at 14 days post-randomization (DAOH-14) | Assessed 14 days post-randomization |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion criteria
Exclusion criteria
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Frans Wiberg, MD | Contact | +4528741294 | frans.wiberg@regionh.dk | |
| Theis S Itenov, MD, PhD | Contact | theis.skovsgaard.itenov@regionh.dk |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Emergency Medicine, Copenhagen University Hospital - Bispebjerg and Frederiksberg | Copenhagen | 2400 | Denmark |
Not provided
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D007239 | Infections |
| D008107 | Liver Diseases |
| ID | Term |
|---|---|
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000111 | Acetylcysteine |
| D013812 | Therapeutics |
| ID | Term |
|---|---|
| D003545 | Cysteine |
| D000603 | Amino Acids, Sulfur |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Data Safety and Monitoring Board.
| 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 |
| 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. | Assessed at 14 days post-randomization |
| D004066 | Digestive System Diseases |
| D000596 |
| Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |