Protocol summary
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Study aim
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Evaluate efficacy of f NAC on the treatment of acute respiratory distress syndrome in patients undergoing mechanical ventilation
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Design
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Randomized clinical trial including control with a parallel group designed of 60 patients, two phase
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Settings and conduct
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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
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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.
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Main outcome variables
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balance of FIO2/ PAO2 as well as PEEP
General information
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Reason for update
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Acronym
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IRCT registration information
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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
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Registration date
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2020-05-06, 1399/02/17
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-03-11, 1397/12/20
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Expected recruitment end date
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2020-05-30, 1399/03/10
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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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Public title
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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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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old to 60 years old
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Gender
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Both
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Phase
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2
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Groups that have been masked
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- Care provider
- Data analyser
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Person in charge of care and the data analyzer
are not aware of the allocation of groups.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2019-08-16, 1398/05/25
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Ethics committee reference number
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IR.AJUMS.REC.1398.389
Health conditions studied
1
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Description of health condition studied
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Acute respiratory distress syndrome (ARDS)
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ICD-10 code
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J80
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ICD-10 code description
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Acute respiratory distress syndrome
Primary outcomes
1
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Description
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Percent of respiratory index in questioner no 1
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Timepoint
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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.
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Method of measurement
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Mechanical ventilator apparatus
Intervention groups
1
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Description
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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.
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Category
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Other
2
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Description
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Control group: Receive routine medical care.
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Category
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Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Ahvaz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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Article
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When the data will become available and for how long
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2021
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To whom data/document is available
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Researchers
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Under which criteria data/document could be used
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No criteria was defined for access the data
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From where data/document is obtainable
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Dr.Mahboobeh Rashidi
Dr.Mojtaba Ghorbi
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What processes are involved for a request to access data/document
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No processes were defined for access the data
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Comments
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Trial results
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Please tick if results have been published
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Yes
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Summary result posting date
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2021-06-08, 1400/03/18
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Table of baseline comparison
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Participant flow diagram
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Table of variable outcomes' results
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Table of adverse events
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First publication date
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2021-07-07, 1400/04/16
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Abstract of published paper
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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.