NCT05886998

Nebulized Heparin for Prevention of Acute Lung Injury in Smoke Inhalation Injury

Nebulized Heparin for Prevention of Acute Lung Injury in Adult Patients Suffering Smoke Inhalation Injury: a Randomized Controlled Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: Ain Shams University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Smoke Inhalation Injury
• Acute Lung Injury

Interventions

Type	Name	Description
DRUG	Heparin	Heparin sodium (Generic, 5000 IU/ml ampoules)
OTHER	Normal Saline	0.9% sodium chloride solution (normal saline)

Timeline

• Start date: 2023-06-01
• Primary completion: 2024-06-03
• Completion: 2024-06-03
• First posted: 2023-06-02
• Last updated: 2024-12-12

Locations

1 site across 1 country: Egypt