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Study aim
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The effect of inhaled amikacin in preventing ventilator-induced pneumonia in patients hospitalized in ICUs of Valiasr Hospital is being investigated
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Design
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Clinical trial with control group, with parallel groups, double-blind, randomized, phase 3 on 126 patients. Block method was used for randomization.
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Settings and conduct
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Intensive care units of Arak Valiasr hospital
The present study will be a double-blind clinical trial study. Patients were randomized by block method and will be divided into two groups in the form of 4 blocks.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: age 18 years or older, absence of lung disease and lung mass, absence of chemotherapy drugs, absence of enteral nutrition, absence of antibiotics before the start of VAP, absence of kidney disease and chronic failure Kidney with basic glomerular filtration of less than 30 ml per minute, the patient's tracheal tube not coming out within the next 48 hours after implantation, the absence of pregnant or lactating women, GFR greater than 50, lack of sensitivity to amikacin, absence of myasthenia gravis, Absence of covid 19 (PCR negative)
Exclusion criteria: patients who require mechanical ventilation for less than 48 hours (because the risk of VAP in them is low), lack of consent to participate in the study by the guardian, re-intubation, if gfr decreases by more than 20% within 48 hours Amikacin is discontinued
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Intervention groups
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Patients requiring mechanical ventilation in the intensive care unit
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Main outcome variables
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Duration of mechanical ventilation, duration of hospitalization in the ICU, mortality, incidence of early-onset pneumonia and Late onset pneumonia, GFR index, CPIS criterion