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

Phase 2

• Conditions: Multiple trauma.; Unspecified multiple injuries

• Registration Number: IRCT2014010716120N1
• Lead Sponsor: Vice Chancellor for Research of Tehran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 44

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

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.