Investigation of the effect of NAC on the treatment of acute respiratory distress syndrome in patients undergoing mechanical ventilation in the intensive care unit
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Ethics committees
#1
IR.AJUMS.REC.1398.713
IR.AJUMS.REC.1398.389
IR.AJUMS.REC.1398.713IR.AJUMS.REC.1398.389
Recruitment centers
#1
Name of recruitment center - English: Imam khumaini hospital, Ahvaz
Name of recruitment center - Persian: بیمارستان امام خمینی اهواز
Full name of responsible person - English: mojtaba ghorbi- mahbubeh rashidi
Full name of responsible person - Persian: مجتبی قربی-محبوبه رشیدی
Street address - English: Ahvaz- Azadegan ave- imam khumaini center for training and trapy
Street address - Persian: اهواز. خیابان آزادگان - مرکز آموزشی درمانی امام خمینی ره
City - English: Ahvaz
City - Persian: اهواز
Province: Khouzestan
Country: Iran (Islamic Republic of)
Postal code: 6193673111
Phone: +98 61 3222 2922
Fax:
Email: Imamhospital@ajums.ac.ir
Web page address:
Name of recruitment center - English: Imam Khumaini Hospital, Ahvaz
Name of recruitment center - Persian: بیمارستان امام خمینی اهواز
Full name of responsible person - English: Mojtaba Ghorbi- Mahbubeh Rashidi
Full name of responsible person - Persian: مجتبی قربی-محبوبه رشیدی
Street address - English: Imam Khomeini University Hospital, Azdehgan Ave, Ahvaz, Khuzestan, Iran
Street address - Persian: ایران، خوزستان،اهواز، خیابان آزادگان ، مرکز آموزشی درمانی امام خمینی ره
City - English: Ahvaz
City - Persian: اهواز
Province: Khouzestan
Country: Iran (Islamic Republic of)
Postal code: 6193673111
Phone: +98 61 3222 2922
Fax:
Email: Imamhospital@ajums.ac.ir
Web page address:
Name of recruitment center - English: Imam khumaini hospitalKhumaini Hospital, Ahvaz Name of recruitment center - Persian: بیمارستان امام خمینی اهواز Full name of responsible person - English: mojtaba ghorbiMojtaba Ghorbi- mahbubeh rashidiMahbubeh Rashidi Full name of responsible person - Persian: مجتبی قربی-محبوبه رشیدی Street address - English: Imam Khomeini University Hospital, Azdehgan Ave, Ahvaz- Azadegan ave- imam khumaini center for training and trapy, Khuzestan, Iran Street address - Persian: ایران، خوزستان،اهواز.، خیابان آزادگان -، مرکز آموزشی درمانی امام خمینی ره City - English: Ahvaz City - Persian: اهواز Province: Khouzestan Country: Iran (Islamic Republic of) Postal code: 6193673111 Phone: +98 61 3222 2922 Fax: Email: Imamhospital@ajums.ac.ir Web page address:
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Mahboobeh Rashidi
Full name of responsible person - Persian: محبوبه رشیدی
Street address - English: Khusestan-Ahvaz-Golestan blv- Ahvaz University of Medical Sciences
Street address - Persian: خوزستان-اهواز- بلوار گلستان دانشگاه علوم پزشکی جندی شاپور اهواز - دانشکده پزشكي
City - English: Ahvaz
City - Persian: اهواز
Province: Khouzestan
Country: Iran (Islamic Republic of)
Postal code: 6135715794
Phone: +98 61 3373 8571
Fax:
Email: rashidi-m@ajums.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Mahboobeh Rashidi
Full name of responsible person - Persian: محبوبه رشیدی
Street address - English: School of Medicine, Ahvaz Jundishapur University of Medical Sciences, Golestan Ave, Ahvaz, Khuzestan, Iran
Street address - Persian: ایران،خوزستان،اهواز، خیابان گلستان، دانشگاه علوم پزشکی جندی شاپور اهواز ، دانشکده پزشكي
City - English: Ahvaz
City - Persian: اهواز
Province: Khouzestan
Country: Iran (Islamic Republic of)
Postal code: 6135715794
Phone: +98 61 3373 8571
Fax:
Email: rashidi-m@ajums.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Mahboobeh Rashidi Full name of responsible person - Persian: محبوبه رشیدی Street address - English: Khusestan-Ahvaz-Golestan blv-School of Medicine, Ahvaz Jundishapur University of Medical Sciences, Golestan Ave, Ahvaz, Khuzestan, Iran Street address - Persian: ایران،خوزستان-،اهواز- بلوار، خیابان گلستان، دانشگاه علوم پزشکی جندی شاپور اهواز -، دانشکده پزشكي City - English: Ahvaz City - Persian: اهواز Province: Khouzestan Country: Iran (Islamic Republic of) Postal code: 6135715794 Phone: +98 61 3373 8571 Fax: Email: rashidi-m@ajums.ac.ir Web page address:
Protocol summary
Study aim
Evaluate efficacy of f NAC on the treatment of acute respiratory distress syndrome in patients undergoing mechanical ventilation
Design
Randomized clinical trial including control with a parallel group designed of 60 patients, two phase
Settings and conduct
60 Patients were randomly divided into two equal groups: the NAC group, which received routine medical care as well as 150 mg/kg day oneand therapy will contentious as 50 mg/kg between 2-4 days.
The control group,will receive routine medical care.
Follow-up:
The following intraoperative clinical variables were recorded :
The primary objective and endpoint is to assess the effect of iloprost on the improvement of oxygenation (PaO2/FiO2 ratio) in patients with ARDS.
-PEEP ratio for more effective mechanical vetilation
-APACHEH II score
-ICU length of stay
-Duration of mechanical ventilation support
- mortality rate and
-FRC
the parameter will record within 4 days.
Place of Study : Imam Khomeini Hospital; Ahvaz;Iran
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Mechanical ventilation more than 48 hours
PaO2/FiO2 ratio ≥ 200 mmhg
PEEP≥ 10 cm H2O
Bilateral Pulmonary infiltrates on the chest x ray
Exclusion ceriteria:
atients who not signed an informed consent form
patients with cardiac and pulmonary disease
pulmonary hypertension
Viral and bacterial diseases including acquired immunodeficiency syndrome (AIDS),hepatitis, pulmonary tuberculosis
History of chemotherapy
The use of immunosuppressive drugs within the last three months
History of organ transplantation within the last two years
Proven brain death
Sensitivity to NAC
Intervention groups
the NAC group, which received routine medical care as well as 150 mg/kg day one through the intravenous injection and therapy will contentious as 50 mg/kg between 2-4 days.
Main outcome variables
balance of FIO2/ PAO2 as well as PEEP
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200425047201N1
Registration date:2020-05-06, 1399/02/17
Registration timing:registered_while_recruiting
Last update:2020-09-01, 1399/06/11
Update count:2
Registration date
2020-05-06, 1399/02/17
Registrant information
Name
Mojtaba Ghorbi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3235 0348
Email address
ghorbi.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-11, 1397/12/20
Expected recruitment end date
2020-05-30, 1399/03/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the effect of NAC on the treatment of acute respiratory distress syndrome in patients undergoing mechanical ventilation in the intensive care unit
Public title
Investigation of the effect of NAC on the treatment of acute respiratory distress syndrome in patients undergoing mechanical ventilation in the intensive care unit
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Mechanical ventilation more than 48 hours
PaO2/FiO2 ratio ≥ 200 mmhg
PEEP≥ 10 cm H2O
Bilateral pulmonary infiltrates on the chest x ray
Exclusion criteria:
Patients who signed an informed consent form
Patients with cardiac and pulmonary disease
Pulmonary hypertension
Viral and bacterial diseases including acquired immunodeficiency syndrome (AIDS),hepatitis, pulmonary tuberculosis
History of chemotherapy
The use of immunosuppressive drugs within the last three months
Sensitivity to NAC
History of transplantation within the last two years
Age
From 18 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
Care provider
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done by simple randome method, after identifying eligible patients, they will be randomly assigned a tree-digit proprietary code. The last digit on the right determines the patient group.If the figure is 0,1,2,3,4 it will be placed in the intervention group(NAC) and if the figure is 5,6,7,8,9 it will be placed in the control group
Blinding (investigator's opinion)
Double blinded
Blinding description
Person in charge of care and the data analyzer
are not aware of the allocation of groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethic Committee of Joundishapour University of Medical Sciences
Street address
School of Medicine, Ahvaz Jundishapur University of Medical Sciences, Golestan Ave, Ahvaz,Khusestan, Iran
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2019-08-16, 1398/05/25
Ethics committee reference number
IR.AJUMS.REC.1398.389
Health conditions studied
1
Description of health condition studied
Acute respiratory distress syndrome (ARDS)
ICD-10 code
J80
ICD-10 code description
Acute respiratory distress syndrome
Primary outcomes
1
Description
Percent of respiratory index in questioner no 1
Timepoint
The NAC group, which received routine medical care as well as 150 mg/kg day one through the intravenous injection and therapy will contentious as 50 mg/kg between 2-4 days.
Method of measurement
Mechanical ventilator apparatus
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: the NAC group, which received routine medical care as well as 150 mg/kg day one through the intravenous injection and therapy will contentious as 50 mg/kg between 2-4 day.
Category
Other
2
Description
Control group: Receive routine medical care.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khumaini Hospital, Ahvaz
Full name of responsible person
Mojtaba Ghorbi- Mahbubeh Rashidi
Street address
Imam Khomeini University Hospital, Azdehgan Ave, Ahvaz, Khuzestan, Iran
City
Ahvaz
Province
Khouzestan
Postal code
6193673111
Phone
+98 61 3222 2922
Email
Imamhospital@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mahboobeh Rashidi
Street address
School of Medicine, Ahvaz Jundishapur University of Medical Sciences, Golestan Ave, Ahvaz, Khuzestan, Iran
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8571
Email
rashidi-m@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mojtaba Ghorbi
Position
Medical Student of Anesthesiology and pain
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
School of Medicine, Ahvaz Jundishapur University of Medical Sciences, Golestan Ave, Ahvaz, Khuzestan, Iran
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 41 3235 0348
Email
ghorbi.m@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mojtaba Ghorbi
Position
Medical Student of Anesthesiology and pain
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
School of Medicine, Ahvaz Jundishapur University of Medical Sciences, Golestan Ave, Ahvaz, Khuzestan, Iran
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 41 3235 0348
Email
ghorbi.m@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mojtaba Ghorbi
Position
Medical Student of Anesthesiology and pain
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
School of Medicine, Ahvaz Jundishapur University of Medical Sciences, Golestan Ave, Ahvaz, Khuzestan, Iran
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 41 3235 0348
Email
ghorbi.m@ajums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Article
When the data will become available and for how long
2021
To whom data/document is available
Researchers
Under which criteria data/document could be used
No criteria was defined for access the data
From where data/document is obtainable
Dr.Mahboobeh Rashidi
Dr.Mojtaba Ghorbi
What processes are involved for a request to access data/document