Individualized Multiplex Pathophysiological Treatment of Severe Acute Infections: N-Acetylcysteine
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorTheis S. Itenov
About this 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?
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
This trial does not accept healthy volunteersQualifiers
Age ≥18 years
Documented clinical suspicion of infection
Model for end-stage liver disease (MELD) score ≥9
Disqualifiers
Admitted to hospital >24 hours before randomization
Any previous severe anaphylaxis
Other known allergy to N-acetylcysteine
Ongoing treatment with N-acetylcysteine at randomization
Trial design
Design model
Parallel
Treatments tested in this trial
N-Acetylcysteine (NAC) Treatment
DrugIntravenous infusion of N-acetylcysteine (200 mg/kg mixed with normal saline to a final volume of 500 ml) administered over four hours.
Treatment groups
360 Participants
are divided into 2 treatment groupsGroup A: N-acetylcysteineExperimental treatment 1 intervention
Group B: Placebo (normal saline)No intervention 0 interventions
Trial outcomes
Primary outcomes
1
Days alive and out of hospital at 14 days post-randomization (DAOH-14)
Time frame
Assessed 14 days post-randomizationSecondary outcomes
1
Number of participants with one or more serious adverse event within 14 days of randomization
Time frame
Assessed 14 days post-randomization2
All-cause mortality at day 180
Time frame
Assessed at 180 days post-randomization3
Health-related quality of life (HRQoL) at day 180 using EQ-5D-5L
Time frame
Assessed 180 days post-randomization4
Admission to an intensive care unit (ICU) within 14 days of admission
Time frame
Assessed at 14 days post-randomizationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Theis S. Itenov
Lead sponsor
University Hospital Bispebjerg and Frederiksberg
Sponsor institution
University Hospital Bispebjerg and Frederiksberg
Collaborator
Source ClinicalTrials.gov