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

Acute Lung Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05886998
• Other study ID #: FMASU MD 238/2020
• Status: Recruiting
• Phase: Phase 3
• Start date: November 1, 2021
• Est. completion date: September 30, 2023

Study information

• Verified date: May 2023
• Source: Ain Shams University
• Contact: Sameh M Hakim, MD
• Phone: +201286824970
• Email: hakimsm[@]med.asu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to examine the value of nebulized heparin for prevention of acute lung injury 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.

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. Occurrence of acute lung injury will be assessed everyday for a maximum of 28 days. The primary end point is the occurrence of acute lung injury defined as defined by the Murray Lung Injury Score.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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. -

Related Conditions & MeSH terms

• Acute Lung Injury
• Lung Injury
• Respiratory Aspiration
• Smoke Inhalation Injury
• Wounds and Injuries

Intervention

Drug:
• Heparin
Heparin sodium (Generic, 5000 IU/ml ampoules)

Other:
• Normal Saline
0.9% sodium chloride solution (normal saline)

Locations

Country	Name	City	State
Egypt	Ain Shams University Hospitals	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

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. Erratum In: Am Rev Respir Dis 1989 Apr;139(4):1065. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of acute lung injury	Acute lung injury is defined according to the Murray Lung Injury Score which comprises 4 items: chest radiograph, PaO2/FiO2, level of PEEP and pulmonary compliance.; Each of the 4 items is assigned a score from 0 to 4. The scores are then summed up and the total score is divided by the number of scored items and is interpreted as follows: 0 = no lung injury.; 0.1-2.5 = mild to moderate lung injury.; >2.5 = severe lung injury. (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. Erratum in: Am Rev Respir Dis 1989 Apr;139(4):1065. PMID: 3202424.)	28 days
Primary	Occurrence of severe acute lung injury	Murray Lung Injury Score >2.5	28 days
Secondary	Duration of mechanical ventilation	Time from institution to termination of mechanical ventilation	28 days
Secondary	Mortality	Survival to ICU discharge	28 days
Secondary	Side effects	Occurrence of heparin-induced adverse effects, e.g., thrombocytopenia, abnormal bleeding	28 days