Nebulized Furosemide, Heparin, Hypertonic Saline in Mechanically Ventilated Acute Respiratory Distress Syndrome Adult Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: nebulization.
- Who it may be relevant to
- Registry conditions: Respiratory Distress Syndrome, Mechanical Ventilation Complication. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Nebulized Furosemide, Heparin, Hypertonic Saline in Mechanically Ventilated Acute Respiratory Distress Syndrome Adult Patients: A Randomized Controlled Clinical Trial
Overview
There are no specific drugs or therapies available to directly treat/prevent ARDS. Mechanical ventilation with an aim to minimize Ventilator Induced Lung Injury (VILI) and management of refractory hypoxemia are the keystones in supportive management of ARDS.
Detailed description
Furosemide: Nebulized furosemide has been studied as a potential treatment option for ARDS patients due to its diuretic properties and potential to reduce pulmonary edema. Research on the effectiveness of furosemide nebulization in ARDS patients could provide valuable insights into its potential role in managing respiratory distress and improving outcomes. Furosemide may reduce pulmonary edema via diuretic and anti-inflammatory effects.
Heparin: Nebulized heparin has been proposed as a treatment for ARDS patients due to its anti-inflammatory and anticoagulant effects. By investigating the effectiveness of heparin nebulization in reducing pulmonary inflammation and improving oxygenation in ARDS patients, clinicians can gain a better understanding of its therapeutic potential in this critical condition. - ARDS involves fibrin deposition in alveoli, worsening compliance. Heparin may reduce microthrombosis and inflammation (anti-TNF-α effects).
Hypertonic saline: Nebulized hypertonic saline has been suggested as a potential therapy for ARDS patients due to its ability to reduce airway inflammation and improve mucociliary clearance. Examining the effectiveness of hypertonic saline nebulization in ARDS patients could offer valuable insights into its impact on respiratory function and recovery in this challenging patient population. Hypertonic saline may improve mucus clearance and alveolar fluid absorption.
Interventions
- Drug nebulization
Study solutions will be administered via a vibrating mesh nebulizer (Aerogen® Pro, Aerogen Ltd, Ireland) placed at the Y-piece of the ventilator circuit, proximal to the patient. The nebulizer will be used with its specific T-piece adapter. The nebulizer will be placed at the Y-piece (proximal to the patient), between the endotracheal tube and the circuit. To optimize aerosol delivery, a standardized nebulization protocol will be followed. For the 30-minute duration of each treatment, the ventil
Primary outcome measures
- Murray Lung Injury Score [Time frame: in the morning of 7 days of mechanical ventillation]
Eligibility criteria
Inclusion criteria
- Adult patients (≥18 years)
- ICU admission, mechanical ventilation for < 7 days
- ARDS diagnosed within 24 hours per the Berlin Definition, which includes Chest x-ray showing bilateral opacities, not fully explained by effusions, lung collapse; Respiratory failure not fully explained by cardiac failure or fluid overload, and exclusion of hydrostatic edema (by echocardiography);
- Oxygenation and ventilator settings matching one of the three categories of ARDS: Mild: 200 mmHg < PaO2/FIO2 ≤ 300 mmHg with positive end-expiratory pressure (PEEP) or continuous positive airway pressure (CPAP) ≥ 5 cm H2O. Moderate: 100 mm Hg < PaO2/FIO2 ≤ 200 mm Hg with PEEP ≥ 5 cm H2O. Severe: PaO2/FIO2 ≤ 100 mm Hg with PEEP ≥ 5 cm H2O.
Exclusion criteria
- 1- Pregnant Patient. 2- Refusal to participate in the trial by the patient's guardian. 3- Known allergy to furosemide or heparin. 4- Active major bleeding, recent intracranial hemorrhage 5- End-stage renal disease 6- Severe chronic liver disease. 7- Uncontrolled shock (e.g., high vasopressor doses). 8- Advanced directives limiting care (e.g., do-not-resuscitate orders), which could affect mortality outcomes.
9- Body Mass Index (BMI) > 40 or severe obesity, which can severely impact lung mechanics and confound results.
10- Electrolyte imbalance
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Faculty of medicine, Tanta university — Tanta
Identifiers
NCT: NCT07286409 · nebulized drugs in ARDS