Evaluation of intravenous Acetylcysteine effects on the Plasma concentration of α –Defensin and Gluthation in mechanically ventilated critically traumatic patients.
The study goal is to evaluate the effect of N-Acetylcysteine on the prevention of oxidative stress and immune suppression in critically traumatic patients on mechanical ventilation. Adult patients with ICU admission following trauma are included in the study and patients with renal, hepatic and cardiac dysfunction will be excluded. A total 44 patients will be randomized in the intervention and control groups. The intervention is 3 grams of intravenous N-Acetylcysteine every 6 hours for 72 hours. The effects on length of ICU stay, one month mortality, length of mechanical ventilation dependence, risk of multi-organ damage and changes in serum markers of defensin and IgM as immune system indicators and glutathione as oxidative stress indicator will be compared with control group which only receives routine therapies.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014010716120N1
Registration date:2014-02-23, 1392/12/04
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-02-23, 1392/12/04
Registrant information
Name
Farhad Najmeddin
Name of organization / entity
TUMS
Country
Iran (Islamic Republic of)
Phone
+98 21 8824 6222
Email address
f-najmeddin@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Tehran University of Medical Sciences
Expected recruitment start date
2014-01-30, 1392/11/10
Expected recruitment end date
2015-03-01, 1393/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of intravenous Acetylcysteine effects on the Plasma concentration of α –Defensin and Gluthation in mechanically ventilated critically traumatic patients.
Public title
The effect of Acetylcysteine on prevention of oxidative stress and immunosuppression in the mechanically ventilated critically traumatic patients
Purpose
Treatment
Inclusion/Exclusion 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
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice Chancellor for Research of Tehran University of Medical Sciences
Street address
Ghods St., Keshavarz Crossroad
City
Tehran
Postal code
Approval date
2009-09-23, 1388/07/01
Ethics committee reference number
88-01-33-8503
Health conditions studied
1
Description of health condition studied
Multiple trauma
ICD-10 code
T07
ICD-10 code description
Unspecified multiple injuries
Primary outcomes
1
Description
Immunoglobulin M
Timepoint
baseline, day 1, day 3 and day 5
Method of measurement
laboratory study
2
Description
Glutathione
Timepoint
baseline, day 1, day 3 and day 5
Method of measurement
laboratory study
3
Description
human β-defensin 2
Timepoint
baseline, day 1, day 3 and day 5
Method of measurement
laboratory study
Secondary outcomes
1
Description
SOFA score
Timepoint
baseline, days 1,2,3,4 and 5
Method of measurement
standard chart
2
Description
WBC
Timepoint
baseline, days 1,2,3,4 and 5
Method of measurement
laboratory study
3
Description
Absolute neutrophil count
Timepoint
baseline, days 1,2,3,4 and 5
Method of measurement
laboratory study
Intervention groups
1
Description
3 grams of NAC every 6 hours with slow intravenous infusion for 72 hours
Category
Treatment - Drugs
2
Description
No specific intervention in control group other than routine treatment
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
General ICU of Sina hospital
Full name of responsible person
Professor Mojtaba Mojtahedzadeh
Street address
Imam khomeyni St., Before Hasan-abad Sq.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research of Tehran University of Medical Sciences
Full name of responsible person
Mrs. Saeedi
Street address
Pursina St.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research of Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Pharmaceutical Sciences Research Center of the Tehran University of Medical Sciences
Full name of responsible person
professor Mojtaba Mojtahedzadeh
Position
full professor in clinical pharmacy
Other areas of specialty/work
Street address
Clinical pharmacy department, Faculty of pharmacy, Tehran University of Medical Sciences, 16Azar st.
City
Tehran
Postal code
Phone
+98 21 64120
Fax
Email
mojtahed@sina.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Pharmaceutical Sciences Research Center of the Tehran University of Medical Sciencesr
Full name of responsible person
professor Mojtaba Mojtahedzadeh
Position
full professor in clinical pharmacy
Other areas of specialty/work
Street address
Clinical pharmacy department, Faculty of pharmacy, Tehran University of Medical Sciences, 16Azar st.