Clinical trial NCT05886998: Nebulized Heparin for Prevention of Acute Lung Injury in Smoke Inhalation Injury
Official title: Nebulized Heparin for Prevention of Acute Lung Injury in Adult Patients Suffering Smoke Inhalation Injury: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Smoke Inhalation Injury
Acute Lung Injury
Keywords: Smoke Inhalation Injury
Acute Lung Injury
Heparin
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-06-02
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. Adult patients indicated for elective intubation:

* 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:

1. Burn injury \> 24 hours.
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. -

Primary outcomes:
measure: VFDs
timeFrame: 28 days
Secondary outcomes:
measure: ICU-free days
timeFrame: 28 days
measure: Duration of mechanical ventilation
timeFrame: 28 days
measure: Mortality
timeFrame: 28 days
measure: Side effects
timeFrame: 28 days
measure: P/F ratio
timeFrame: 14 days
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University Hospitals
Study officials:
affiliation: Ain Shams University Faculty of Medicine
name: Sameh M Hakim, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.