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The effect of Acetylcysteine on prevention of oxidative stress and immunosuppression in the mechanically ventilated critically traumatic patients

Evaluation of intravenous Acetylcysteine effects on the Plasma concentration of a –Defensin and Gluthation in mechanically ventilated critically traumatic patients.

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT2014010716120N1
Enrollment
44
Registered
2014-02-23
Start date
2014-01-30
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

Multiple trauma. Unspecified multiple injuries

Interventions

Intervention 1: 3 grams of NAC every 6 hours with slow intravenous infusion for 72 hours. Intervention 2: No specific intervention in control group other than routine treatment.
Treatment - Drugs
3 grams of NAC every 6 hours with slow intravenous infusion for 72 hours
No specific intervention in control group other than routine treatment

Sponsors

Vice Chancellor for Research of Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: ICU admission fallowing trauma; need for mechanical ventilation ; FiO2 more than 50% ; At least two Systemic Inflammatory Response(SIRS) criteria (Body temperature more than 38°C or less than 36°C, Heart rate more than 90 beats/min, Respiratory rate more than 20 breath/min or PaCo2 less than 32 mm Hg, WBC more than 12,000 cells/mm3, or less than 4000 cells/mm3, or more than 10% immature (band) cells) Exclusion criteria:Age lower than 18 ; Acute Physiology and Chronic Health Evaluation(APACHE) II score lower than 15 ; Central Venous Pressure (CVP) > 18 mmHg ; Systolic Blood Pressure < 90 mmHg or Mean Arterial Pressure (MAP) < 60 mmHg ; Serum Creatinine = 2 mg/dl; urine output less than 0.5 ml/Kg/hour; liver dysfunction (defined as the presence of hepatic cirrhosis or concentration of serum trans-aminases greater than third times the upper limit of normal range) ; history of myocardial infarction or heart failure (EF< 40%) and those received N-acetyl Cysteine (NAC) before initiation of study were excluded from the study

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Immunoglobulin M. Timepoint: baseline, day 1, day 3 and day 5. Method of measurement: laboratory study.;Glutathione. Timepoint: baseline, day 1, day 3 and day 5. Method of measurement: laboratory study.;Human ß-defensin 2. Timepoint: baseline, day 1, day 3 and day 5. Method of measurement: laboratory study.

Secondary

MeasureTime frame
SOFA score. Timepoint: baseline, days 1,2,3,4 and 5. Method of measurement: standard chart.;WBC. Timepoint: baseline, days 1,2,3,4 and 5. Method of measurement: laboratory study.;Absolute neutrophil count. Timepoint: baseline, days 1,2,3,4 and 5. Method of measurement: laboratory study.

Countries

Iran (Islamic Republic of)

Contacts

Public Contactprofessor Mojtaba Mojtahedzadeh

Pharmaceutical Sciences Research Center of the Tehran University of Medical Sciences

mojtahed@sina.tums.ac.ir+98 21 64120

Outcome results

None listed

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