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

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.

Study Overview

• Status: Completed
• Conditions: Acute Lung Injury; Smoke Inhalation Injury
• Intervention / Treatment: Drug: Heparin; Other: Normal Saline

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.

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11517
    • Ain shams university hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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. -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A (Nebulized Heparin); Heparin is nebulized via endotracheal tube	Drug: Heparin; Heparin sodium (Generic, 5000 IU/ml ampoules)
Placebo Comparator: Group B (Nebulized Saline); Normal saline is nebulized via endotracheal tube	Other: Normal Saline; 0.9% sodium chloride solution (normal saline); Other Names: Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VFDs	Number of days free of mechanical ventilation	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of mechanical ventilation	Time from institution to termination of mechanical ventilation	28 days
Mortality	Survival to ICU discharge	28 days
Side effects	Occurrence of heparin-induced adverse effects, e.g., thrombocytopenia, abnormal bleeding	28 days
ICU-free days	Number of days free from ICU and alive	28 days
P/F ratio	PaO2/FiO2	14 days

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Principal Investigator: Sameh M Hakim, MD, Ain Shams University Faculty of Medicine

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Actual): June 3, 2024
• Study Completion (Actual): June 3, 2024

Study Registration Dates

• First Submitted: May 22, 2023
• First Submitted That Met QC Criteria: May 31, 2023
• First Posted (Actual): June 2, 2023

Study Record Updates

• Last Update Posted (Estimated): December 12, 2024
• Last Update Submitted That Met QC Criteria: December 9, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Heparin; Acute Lung Injury; Smoke Inhalation Injury
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Respiration Disorders; Thoracic Injuries; Burns; Burns, Inhalation; Wounds and Injuries; Respiratory Aspiration; Lung Injury; Acute Lung Injury; Smoke Inhalation Injury; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Fibrinolytic Agents; Anticoagulants; Heparin
• Other Study ID Numbers: FMASU MD 238/2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No