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IRCT20200425047201N1 IRCT 2020-05-06 Ahvaz University of Medical Sciences Investigation of the effect of NAC on the treatment of acute respiratory distress syndrome in patients undergoing mechanical ventilation in the intensive care unit Investigation of the effect of NAC on the treatment of acute respiratory distress syndrome in patients undergoing mechanical ventilation in the intensive care unit 2019-03-11 anticipated 60 Complete https://irct.ir/trial/47493 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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 description: Person in charge of care and the data analyzer are not aware of the allocation of groups. 2 Acute respiratory distress syndrome (ARDS). Intervention 1: 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. Intervention 2: Control group: Receive routine medical care. http://mjiri.iums.ac.ir/article-1-7288-en.html 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. Yes - There is a plan to make this available What will be shared: Article When: 2021 To whom: Researchers Conditions: No criteria was defined for access the data Where to obtain: Dr.Mahboobeh Rashidi Dr.Mojtaba Ghorbi How to obtain: No processes were defined for access the data Comments:
public Mojtaba Ghorbi
School of Medicine, Ahvaz Jundishapur University of Medical Sciences, Golestan Ave, Ahvaz, Khuzestan, Iran
Ahvaz Iran (Islamic Republic of) 6135715794 +98 41 3235 0348 ghorbi.m@ajums.ac.ir Ahvaz University of Medical Sciences scientific Mojtaba Ghorbi
School of Medicine, Ahvaz Jundishapur University of Medical Sciences, Golestan Ave, Ahvaz, Khuzestan, Iran
Ahvaz Iran (Islamic Republic of) 6135715794 +98 41 3235 0348 ghorbi.m@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) Mechanical ventilation more than 48 hours PaO2/FiO2 ratio ≥ 200 mmhg PEEP≥ 10 cm H2O Bilateral pulmonary infiltrates on the chest x ray 18 years 60 years Both 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 J80 Acute respiratory distress syndrome Other Other 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. Control group: Receive routine medical care. 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. Ahvaz University of Medical Sciences Approved 2019-08-16 Research Ethic Committee of Joundishapour University of Medical Sciences School of Medicine, Ahvaz Jundishapur University of Medical Sciences, Golestan Ave, Ahvaz,Khusestan, Iran Ahvaz Khouzestan Iran (Islamic Republic of)