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Completed

NCT Number: NCT05886998

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Ain Shams University Hospitals

Cairo, Cairo Governorate, 11517, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • 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

  • Burn injury > 24 hours.
  • History of pulmonary diseases.
  • Pregnancy or breast feeding.
  • History of allergy to heparin or HIT.
  • History or laboratory evidence of coagulopathy.
  • Burns area > 50% of total body surface area. -

Treatment and study plan

Heparin

Drug

Heparin sodium (Generic, 5000 IU/ml ampoules)

Normal Saline

Other

0.9% sodium chloride solution (normal saline)

Other names: Saline

Primary outcomes

  1. VFDs

    Time frame: 28 days

    Number of days free of mechanical ventilation

Secondary outcomes

  1. ICU-free days

    Time frame: 28 days

    Number of days free from ICU and alive

  2. Duration of mechanical ventilation

    Time frame: 28 days

    Time from institution to termination of mechanical ventilation

  3. Mortality

    Time frame: 28 days

    Survival to ICU discharge

  4. Side effects

    Time frame: 28 days

    Occurrence of heparin-induced adverse effects, e.g., thrombocytopenia, abnormal bleeding

  5. P/F ratio

    Time frame: 14 days

    PaO2/FiO2

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 2, 2023
Registry last updated
Dec 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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