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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Background and Objectives: N-acetylcysteine is an antioxidant derived from the amino acid cysteine and is one of the drugs used in the treatment of respiratory diseases. The aim of this study was to investigate the effect of N-acetylcysteine on the treatment of acute respiratory distress syndrome in mechanically ventilated patients admitted to the intensive care unit.
Methods: This study was a randomized clinical trial. Patients under mechanical ventilation admitted to the intensive care unit were examined. Patients in the intervention group received 150 mg/kg of NAC drug internally. Intravenously received on the first day of hospitalization and then 50 mg/kg on the first to fourth days. Patients in the control group will receive routine care. The vital signs, level of consciousness of patients, and another important variable were recorded. Data were analyzed using statistical tests and SPSS software version 24.
Results: There was no significant difference between MAP, heart rate, respiratory rate, O2Sat, APACHE II score and pulmonary capacity of patients in the two groups on the first, second, third and fourth days after the intervention (P>0.05 ). There was no significant difference between level of consciousness (according to GCS criteria), respiratory index (PAO2/FIO2) and PEEP of patients in the two study groups within 1 to 2 days after the intervention (P>0.05). There was a significant difference between level of consciousness (based on GCS criteria), respiratory index (PAO2/FIO2) and PEEP of patients in the two study groups within 3 to 4 days after the intervention (P<0.05). There was no significant difference between the duration of hospitalization in the ICU, the time required for mechanical ventilation and the mortality rate of patients in the two groups (P>0.05).
Conclusion: It seems that N-acetylcysteine has a positive effect on the treatment of acute respiratory distress syndrome in mechanically ventilated patients admitted to the intensive care unit.
Background and Objectives: N-acetylcysteine is an antioxidant derived from the amino acid cysteine and is one of the drugs used in the treatment of respiratory diseases. The aim of this study was to investigate the effect of N-acetylcysteine on the treatment of acute respiratory distress syndrome in mechanically ventilated patients admitted to the intensive care unit. Methods: This study was a randomized clinical trial. Patients under mechanical ventilation admitted to the intensive care unit were examined. Patients in the intervention group received 150 mg/kg of NAC drug internally. Intravenously received on the first day of hospitalization and then 50 mg/kg on the first to fourth days. Patients in the control group will receive routine care. The vital signs, level of consciousness of patients, and another important variable were recorded. Data were analyzed using statistical tests and SPSS software version 24. Results: There was no significant difference between MAP, heart rate, respiratory rate, O2Sat, APACHE II score and pulmonary capacity of patients in the two groups on the first, second, third and fourth days after the intervention (P>0.05 ). There was no significant difference between level of consciousness (according to GCS criteria), respiratory index (PAO2/FIO2) and PEEP of patients in the two study groups within 1 to 2 days after the intervention (P>0.05). There was a significant difference between level of consciousness (based on GCS criteria), respiratory index (PAO2/FIO2) and PEEP of patients in the two study groups within 3 to 4 days after the intervention (P<0.05). There was no significant difference between the duration of hospitalization in the ICU, the time required for mechanical ventilation and the mortality rate of patients in the two groups (P>0.05). Conclusion: It seems that N-acetylcysteine has a positive effect on the treatment of acute respiratory distress syndrome in mechanically ventilated patients admitted to the intensive care unit.
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چکیده
هدف: داروی ان استیل سیستئین به عنوان یک آنتی اکسیدان مشتقی از اسید آمینه ی سیستئین است و از جمله داروهایی است که در درمان بیماری های تنفسی مورد استفاده قرار می گیرد. هدف از انجام این مطالعه، بررسی تاثیر ان استیل سیستئین بر درمان سندروم دیسترس تنفسی حاد در بیماران تحت تهویه ی مکانیکی بستری در بخش مراقبت های ویژه بیمارستان امام خمینی (ره) اهواز، در سال 1399 است.
روش کار: این مطالعه از نوع کارآزمایی بالینی است. دراین مطالعه بیماران بیماران تحت تهویه ی مکانیکی بستری در بخش مراقبت های ویژه بیمارستان امام خمینی (ره) اهواز، در سال 1399 بررسی شدند، بیماران گروه مداخله علاوه بر مراقبت های روتین، به میزان 150 میلی گرم بر کیلوگرم داروی NAC بصورت داخل وریدی در روز اول بستری و سپس 50 میلی گرم بر کیلوگرم در روزهای دوم تا چهارم ، دریافت کرد.ند بیماران گروه کنترل تحت مراقبت های روتین خواهند بود. علاوه بر علائم حیاتی و سطح هوشیاری بیماران، ایندکس تنفسی (PAO2/FIO2)، میزان PEEP مورد نیاز جهت تهویه مکانیکی موثر، نمره ی APACHE II، مدت زمان بستری در ICU، مدت زمان مورد نیاز جهت تهویه مکانیکی، میزان مرگ و میر و ظرفیت ریوی بیماران هر دو گروه، در طول دوره 4 روزه مطالعه و ثبت شد. داده ها با استفاده از آزمون های آماری و نرم افزار SPSS ویرایش 22 تجزیه و تحلیل گردید.
نتایج: بین فشار خون متوسط شریانی، ضربان قلب، تعداد تنفس، ﺩﺭﺻد ﺍﺷﺒﺎﻉ ﺍﻛﺴﻴﮋﻥ، نمره APACHE II و ظرفیت ریوی بیماران در 2 گروه مورد مطالعه در روز اول، دوم، سوم و چهارم بعد از مداخله تفاوت معناداری وجود ندارد (0.05P). بین مدت زمان بستری در ICU، مدت زمان مورد نیاز جهت تهویه مکانیکی و میزان مرگ و میر بیماران در 2 گروه مورد مطالعه تفاوت معناداری وجود ندارد (0.05
چکیده هدف: داروی ان استیل سیستئین به عنوان یک آنتی اکسیدان مشتقی از اسید آمینه ی سیستئین است و از جمله داروهایی است که در درمان بیماری های تنفسی مورد استفاده قرار می گیرد. هدف از انجام این مطالعه، بررسی تاثیر ان استیل سیستئین بر درمان سندروم دیسترس تنفسی حاد در بیماران تحت تهویه ی مکانیکی بستری در بخش مراقبت های ویژه بیمارستان امام خمینی (ره) اهواز، در سال 1399 است. روش کار: این مطالعه از نوع کارآزمایی بالینی است. دراین مطالعه بیماران بیماران تحت تهویه ی مکانیکی بستری در بخش مراقبت های ویژه بیمارستان امام خمینی (ره) اهواز، در سال 1399 بررسی شدند، بیماران گروه مداخله علاوه بر مراقبت های روتین، به میزان 150 میلی گرم بر کیلوگرم داروی NAC بصورت داخل وریدی در روز اول بستری و سپس 50 میلی گرم بر کیلوگرم در روزهای دوم تا چهارم ، دریافت کرد.ند بیماران گروه کنترل تحت مراقبت های روتین خواهند بود. علاوه بر علائم حیاتی و سطح هوشیاری بیماران، ایندکس تنفسی (PAO2/FIO2)، میزان PEEP مورد نیاز جهت تهویه مکانیکی موثر، نمره ی APACHE II، مدت زمان بستری در ICU، مدت زمان مورد نیاز جهت تهویه مکانیکی، میزان مرگ و میر و ظرفیت ریوی بیماران هر دو گروه، در طول دوره 4 روزه مطالعه و ثبت شد. داده ها با استفاده از آزمون های آماری و نرم افزار SPSS ویرایش 22 تجزیه و تحلیل گردید. نتایج: بین فشار خون متوسط شریانی، ضربان قلب، تعداد تنفس، ﺩﺭﺻد ﺍﺷﺒﺎﻉ ﺍﻛﺴﻴﮋﻥ، نمره APACHE II و ظرفیت ریوی بیماران در 2 گروه مورد مطالعه در روز اول، دوم، سوم و چهارم بعد از مداخله تفاوت معناداری وجود ندارد (0.05
P). بین مدت زمان بستری در ICU، مدت زمان مورد نیاز جهت تهویه مکانیکی و میزان مرگ و میر بیماران در 2 گروه مورد مطالعه تفاوت معناداری وجود ندارد (0.05
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:2021-06-08, 1400/03/18
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
Background and Objectives: N-acetylcysteine is an antioxidant derived from the amino acid cysteine and is one of the drugs used in the treatment of respiratory diseases. The aim of this study was to investigate the effect of N-acetylcysteine on the treatment of acute respiratory distress syndrome in mechanically ventilated patients admitted to the intensive care unit.
Methods: This study was a randomized clinical trial. Patients under mechanical ventilation admitted to the intensive care unit were examined. Patients in the intervention group received 150 mg/kg of NAC drug internally. Intravenously received on the first day of hospitalization and then 50 mg/kg on the first to fourth days. Patients in the control group will receive routine care. The vital signs, level of consciousness of patients, and another important variable were recorded. Data were analyzed using statistical tests and SPSS software version 24.
Results: There was no significant difference between MAP, heart rate, respiratory rate, O2Sat, APACHE II score and pulmonary capacity of patients in the two groups on the first, second, third and fourth days after the intervention (P>0.05 ). There was no significant difference between level of consciousness (according to GCS criteria), respiratory index (PAO2/FIO2) and PEEP of patients in the two study groups within 1 to 2 days after the intervention (P>0.05). There was a significant difference between level of consciousness (based on GCS criteria), respiratory index (PAO2/FIO2) and PEEP of patients in the two study groups within 3 to 4 days after the intervention (P<0.05). There was no significant difference between the duration of hospitalization in the ICU, the time required for mechanical ventilation and the mortality rate of patients in the two groups (P>0.05).
Conclusion: It seems that N-acetylcysteine has a positive effect on the treatment of acute respiratory distress syndrome in mechanically ventilated patients admitted to the intensive care unit.