Nebulized Furosemide, Heparin, Hypertonic Saline in Mechanically Ventilated Acute Respiratory Distress Syndrome Adult Patients

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTanta University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • nebulization

    Drug

    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 ventilator will be set to Volume Control or Assist-Control mode with a constant inspiratory flow of 40-50 L/min, an inspiratory-to-expiratory ratio of 1:3, and an end-inspiratory pause of 0.5 seconds. The heated humidifier will be turned off 15 minutes before and bypassed during the nebulization period. Immediately after the 30-minute nebulization is complete, the humidification chamber will be reconnected, and the heated humidifier will be turned back on.

Treatment groups

344 Participants
are divided into 4 treatment groups
Group A: frusemideActive comparator 1 intervention
Group B: heparinActive comparator 1 intervention
Group C: hypertonic salineActive comparator 1 intervention
Group D: controlPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Murray Lung Injury Score

Murray lung injury score will be calculated daily in the morning (8:00 am) based on information obtained from: 1. Number of quadrants of infiltrations from chest X-ray. 2. Hypoxic index. 3. Positive end expiratory pressure (PEEP (cmH2O)) required on the ventilator to get better oxygenation. 4. Static compliance will be calculated daily in the morning (8:00 am) based on information obtained from: a) Number of quadrants of infiltrations from chest X-ray. b) Hypoxic index. c) Positive end expiratory pressure (PEEP (cmH2O)) required on the ventilator to get better oxygenation. d) Static compliance

Time frame
in the morning of 7 days of mechanical ventillation

Secondary outcomes

Other outcomes

Sponsors and contacts

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