Investigation of the effect of NAC on the treatment of acute respiratory distress syndrome in patients undergoing mechanical ventilation in the intensive care unit

Phase 2

Conditions: Acute respiratory distress syndrome (ARDS).
Acute respiratory distress syndrome

Registration Number: IRCT20200425047201N1

Lead Sponsor: Ahvaz University of Medical Sciences

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 60

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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures