This study aims to examine the effects of nebulized heparin on the clinical outcomes in adult patients suffering smoke inhalation injury. Patients will be randomized to receive nebulized heparin or an equal volume of normal saline for 14 days and the incidence of acute lung injury will be compared in either group.
Adult patients who suffered smoke inhalation injury and who are candidates for elective intubation, have evidence of bronchial burn by fiberoptic bronchoscopy, have no evidence of acute lung injury and no more than 24 hours since inhalation injury will be included. Patients will be randomized into 2 groups: Group A (Intervention): Patients will receive 5000 IU heparin mixed with 3 ml saline and nebulized every 4 hours until they are extubated or until 14 days have elapsed whichever is earlier. Group B (Control): Patients will receive 4 ml of normal saline nebulized every 4 hours until they are extubated or until 14 days have elapsed whichever is earlier. The primary end point is the VFDs.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
88
Heparin sodium (Generic, 5000 IU/ml ampoules)
0.9% sodium chloride solution (normal saline)
Ain Shams University Hospitals
Cairo, Cairo Governorate, Egypt
VFDs
Number of days free of mechanical ventilation
Time frame: 28 days
ICU-free days
Number of days free from ICU and alive
Time frame: 28 days
Duration of mechanical ventilation
Time from institution to termination of mechanical ventilation
Time frame: 28 days
Mortality
Survival to ICU discharge
Time frame: 28 days
Side effects
Occurrence of heparin-induced adverse effects, e.g., thrombocytopenia, abnormal bleeding
Time frame: 28 days
P/F ratio
PaO2/FiO2
Time frame: 14 days
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