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IRCT20210405050848N1 IRCT 2021-06-07 Shahid Beheshti University of Medical Sciences Pneumonia Comparison of High Doses of Meropenem with its Usual Dose in increasing the effect of Cholestine on the treatment of ventilator-dependent pneumonitis resulting from Acintobacter 2021-05-20 anticipated 60 Complete https://irct.ir/trial/55408 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: After entering the participants according to the inclusion criteria, the pretest was performed using a ventilator-dependent pneumonia evaluation checklist, then randomly assigned by the head nurse based on blocking. Given that 60 people had to be included in the study and there were two groups (intervention and control), taking into account all possible possibilities, 6 blocks of 4 states were calculated (it is necessary to explain that the number of blocks of the combination formula : C (n , r)= C_r^n=n C r=(n¦r) was obtained), Blinding description: The study is double blind. The drug is prescribed by a physician and injected by a nurse and recorded in a checklist. The patient and the researcher have no role in randomly assigning the samples to the intervention or control group, and the intervention will be performed and the results will be recorded by the relevant nurse. The samples will be analyzed by the center's laboratory expert. The interpretation of the data will be done by the researcher and will be decided based on the interpreted results. 3 Pneumonia. Intervention 1: Intervention group: Continuous infusion of Meropenem(The intervention group will be given a 250 mg dose of Meropenem ampule as a continuous infusion with a pump, and routine infusion of Cleistine will continue in ventilator-associated pneumonia.). Intervention 2: Control group: Infusion each 8 hours of Meropenem (The control group will receive an intravenous infusion of Meropenem at a dose of 1000 mg every 8 hours. Routine infusion of Cleistine will continue in ventilator-associated pneumonia.). No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information
public Jafar Vakili
7th Floor, Bldg No.2 Shahid Beheshti University of Medical Sciences, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran.
Tehran Iran (Islamic Republic of) 1983963113 +98 21 2243 9770 jafar.vakili@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Jafar Vakili
7th Floor, Bldg No.2 Shahid Beheshti University of Medical Sciences, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran.
Tehran Iran (Islamic Republic of) 1983963113 +98 21 2243 9770 jafar.vakili@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Age over 18 years Having at least two VAP criteria (increase in WBC above 11000 and decrease in WBC below 4000, fever above 38.5, culture of pulmonary secretions sensitive to cleistine, changes in CXRay) 18 years no limit Both History of allergy to Meropenem Treatment - Drugs Treatment - Drugs Intervention group: Continuous infusion of Meropenem(The intervention group will be given a 250 mg dose of Meropenem ampule as a continuous infusion with a pump, and routine infusion of Cleistine will continue in ventilator-associated pneumonia.) Control group: Infusion each 8 hours of Meropenem (The control group will receive an intravenous infusion of Meropenem at a dose of 1000 mg every 8 hours. Routine infusion of Cleistine will continue in ventilator-associated pneumonia.) VAP (Ventilation Associated Pneumonia)caused by Acinetobacter. Timepoint: Before and 3 day After intervention. Method of measurement: VAP(Ventilation Associated Pneumonia) criteria. Control of ventilator associated pneumonia. Timepoint: Before and 3 days after intervention. Method of measurement: VAP (Ventilation Associated Pneumonia) criteria. Shahid Beheshti University of Medical Sciences Approved 2021-03-06 Ethics committee of Shahid beheshti University of Medical Sciences th Floor, Bldg No.2 Shahid Beheshti University of Medical Sciences, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)