Ain Shams University Hospitals
Cairo, Cairo Governorate, 11517, Egypt
NCT Number: NCT05886998
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 3
Cairo, Cairo Governorate, 11517, Egypt
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Heparin sodium (Generic, 5000 IU/ml ampoules)
0.9% sodium chloride solution (normal saline)
Other names: Saline
Time frame: 28 days
Number of days free of mechanical ventilation
Time frame: 28 days
Number of days free from ICU and alive
Time frame: 28 days
Time from institution to termination of mechanical ventilation
Time frame: 28 days
Survival to ICU discharge
Time frame: 28 days
Occurrence of heparin-induced adverse effects, e.g., thrombocytopenia, abnormal bleeding
Time frame: 14 days
PaO2/FiO2
Ain Shams University
Other
Nebulized Heparin for Prevention of Acute Lung Injury in Adult Patients Suffering Smoke Inhalation Injury: a Randomized Controlled Trial
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