Absorption of drug N acetylcysteine from gastrointestinal system in severely ill patients

Bioavailability of oral N-acetylcysteine in different intensive care unit patient groups - ACC bioavailability in ICU

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-002093-23-EE

Enrollment

Registered

2011-09-19

Start date

2011-09-21

Completion date

Unknown

Last updated

2025-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe neurotrauma, severe pulmonary infections and severe gastrointestinal disease (eg peritonitis, pancreatitis, ileus, major abdominal surgery etc). Need for liquefaction of viscous sputum

Interventions

Product Name: N-acetylcysteine Pharmaceutical Form: Dispersible tablet INN or Proposed INN: ACETYLCYSTEINE CAS Number: 616-91-1 Current Sponsor code: 1 Other descriptive name: NAC Concentration unit:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: adult 18-65 y N-acetylcysteine indication for sputum liquefaction Reason for ICU admission (only one): severe neurotrauma, severe lung disease (eg. pneumonia, COPD exacerbation) or severe gastrointestinal disease (eg. pancreatitis, peritonitis, major abdominal surgery) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: no informed consent from patient or next to kin relative allergy to N acetylcysteine or durg components enteral feeding intollerance or enteral feeding is contraindicated creatinine clearnace lower than 30 ml/min, calculated using Cokcroft-Gault equation liver dysfunction, defined as increase in AST/ALT more than 2 times reference value and/or hyperbilirubineemia morbid obesity KMI more then 35 kg/m2

Design outcomes

Primary

Measure	Time frame
Main Objective: To measure N acetylcysteine oral bioavailability in different ICU patients: isolated severe neurotrauma, isolated severe lung infection and isolated severe gastrointestinal condition (pancreatitis, peritonitis, major abdominal surgery);Secondary Objective: none;Primary end point(s): Bioavailability of oral N-acetylcysteine;Timepoint(s) of evaluation of this end point: 8 hours after administration	—

Measure

Time frame

Main Objective: To measure N acetylcysteine oral bioavailability in different ICU patients: isolated severe neurotrauma, isolated severe lung infection and isolated severe gastrointestinal condition (pancreatitis, peritonitis, major abdominal surgery);Secondary Objective: none;Primary end point(s): Bioavailability of oral N-acetylcysteine;Timepoint(s) of evaluation of this end point: 8 hours after administration

—

Secondary

Measure	Time frame
Secondary end point(s): none;Timepoint(s) of evaluation of this end point: none	—

Countries

Estonia

Contacts

Public ContactJuri Karjagin

University of Tartu

juri.karjagin@kliinikum.ee+3727318380

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026