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IRCT20120527009886N3 IRCT 2023-04-11 Tehran University of Medical Sciences Investigating and comparing the therapeutic outcomes of two regimens of cholestin therapy through a bronchoscope versus standard treatment in patients with lung infection Investigating and comparing the therapeutic outcomes of two treatment regimens of cholestin instillation (through the bronchoscope) versus standard treatment in patients with ventilator-associated pneumonia (VAP) with resistant gram-negative bacilli. 2023-04-18 anticipated 20 Complete https://irct.ir/trial/69459 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: A computer-generated randomization sequence will be used to allocate eligible participants to either the bronchoscopy group or the standard treatment group. The sequence will be generated by a statistician not involved in the study, using a random number generator with varying block sizes to ensure balance between the two groups. The allocation will be concealed in opaque sealed envelopes, and the study personnel responsible for enrolling participants will open the envelopes sequentially and allocate the participant to the corresponding group. To further reduce the possibility of allocation bias, neither the participants nor the study personnel will be informed of the allocation sequence until after the participant has given informed consent and baseline measurements have been obtained. 3 Ventilator Associated Pneumonia. Intervention 1: Intervention group: Instillation Bronchoscopy. Intervention 2: Control group: Clostin nebulizer. Yes - There is a plan to make this available What will be shared: Data will be coded and will be shared. When: Starting in September 2023 To whom: People working in academic institutions Conditions: Email should be sent from an academic institutions and 1 month will be lasted from sending email and getting data. Where to obtain: Email Morteza Foroomandi How to obtain: Email should be sent from an academic institutions and 1 month will be lasted from sending email and getting data. Comments:
public Mostafa Mohammadi
Keshavarz Blvd., Dr. Gharib St
Tehran Iran (Islamic Republic of) 1416634793 0098.21.61190 mohammady_mm@tums.ac.ir Tehran University of Medical Sciences scientific Mostafa Mohammadi
Keshavarz Blvd., Dr. Gharib St
Tehran Iran (Islamic Republic of) 1416634793 0098.21.61190 mohammady_mm@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Patients with ventilator-associated pneumonia Age between 18 and 75 years Patients who developed pulmonary infection with gram-negative bacilli resistant to several antibiotic drugs after 48 hours of intubation. 18 years 75 years Both Age older than 75 or younger than 18 years Patients with adult respiratory distress syndrome (ARDS) according to the Berlin criteria P/F ratio less than 100 Septic shock requires a dose of norepinephrine with a dose greater than 0.25 Mcg/KG/MIN Patients with infection with other microorganisms J95.851 Ventilator associated pneumonia Treatment - Drugs Treatment - Drugs Intervention group: Instillation Bronchoscopy Control group: Clostin nebulizer Mortality rate. Timepoint: After the start of treatment until the discharge or death of the patient. Method of measurement: Questionnaire. The number of days hospitalized in the intensive care unit. Timepoint: After initiation of treatment until discharge or death from the intensive care unit. Method of measurement: Questionnaire. Tehran University of Medical Sciences Approved 2023-04-02 Teharn University of medical sciences Tehran Province, Tehran, District 6, Pour Sina St, P94V+8MF, Iran Tehran Tehran Iran (Islamic Republic of)