Nebulized Heparin for Prevention of Acute Lung Injury in Smoke Inhalation Injury
NCT ID: NCT05886998
Last Updated: 2024-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
88 participants
INTERVENTIONAL
2023-06-01
2024-06-03
Brief Summary
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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
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Group A (Nebulized Heparin)
Heparin is nebulized via endotracheal tube
Heparin
Heparin sodium (Generic, 5000 IU/ml ampoules)
Group B (Nebulized Saline)
Normal saline is nebulized via endotracheal tube
Normal Saline
0.9% sodium chloride solution (normal saline)
Interventions
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Heparin
Heparin sodium (Generic, 5000 IU/ml ampoules)
Normal Saline
0.9% sodium chloride solution (normal saline)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* History of being trapped in a house or industrial fire.
* Production of carbonaceous sputum.
* Perioral facial burns affecting nose, lips, mouth, or throat .
* Altered level of consciousness at any time after the incident and including confusion.
* Symptoms of respiratory distress including a sense of suffocation, choking, breathlessness, and wheezing or discomfort affecting the eyes or throat, including irritation of the mucosal membranes.
* Signs of respiratory distress including stertorous or labored breathing, and tachypnea or auscultatory abnormalities, including crepitations or rhonchi.
* Hoarseness or loss of voice. 2. Evidence of bronchial burn by bronchoscopy to assess severity of inhalational trauma
* NO injury: absence of carbonaceous deposits, erythema, oedema, brochorrhea, or obstruction.
* Mild injury: minor patchy areas of erythema or carbonaceous deposits in proximal or distal bronchi.
* Moderate injury: moderate degree of erythema, carbonaceous deposits, bronchorrhea, or bronchial obstructions.
* Sever injury: sever inflammation with friability, copious carbonaceous deposits, bronchorrhea, or obstruction.
* Massive injury: evidence of mucosal sloughing, necrosis or endoluminal obliteration.
3\. No evidence of acute lung injury at presentation (either by radiology or ABG)
* Radiological findings: Normal lung without increased interstitial markings, ground glass opacification, or consolidation.
* ABG findings : PaO2/ Fio2 \> 300. 4. Time between inhalational injury and intubation not longer than 24 hours.
Exclusion Criteria
2. History of pulmonary diseases.
3. Pregnancy or breast feeding.
4. History of allergy to heparin or HIT.
5. History or laboratory evidence of coagulopathy.
6. Burns area \> 50% of total body surface area. -
18 Years
ALL
No
Sponsors
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Ain Shams University
OTHER
Responsible Party
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Sameh M. Hakim
Professor
Principal Investigators
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Sameh M Hakim, MD
Role: PRINCIPAL_INVESTIGATOR
Ain Shams University Faculty of Medicine
Locations
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Ain Shams University Hospitals
Cairo, Cairo Governorate, Egypt
Countries
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References
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Murray JF, Matthay MA, Luce JM, Flick MR. An expanded definition of the adult respiratory distress syndrome. Am Rev Respir Dis. 1988 Sep;138(3):720-3. doi: 10.1164/ajrccm/138.3.720. No abstract available.
Other Identifiers
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FMASU MD 238/2020
Identifier Type: -
Identifier Source: org_study_id