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

Tanta University

Status: Not yet enrolling

Conditions: Respiratory Distress Syndrome; Mechanical Ventilation Complication

Treatments: Drug: nebulization

Study type: Interventional

Funder types: Other

Identifiers

NCT07286409

nebulized drugs in ARDS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 344 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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344 participants in 4 patient groups, including a placebo group

frusemide

Active Comparator group

Description:

The furosemide group will receive 40 mg furosemide in 4 ml of 0.9% saline, administered /6 hours for 7 days

Treatment:

Drug: nebulization

heparin

Active Comparator group

Description:

The heparin group will receive inhaled unfractionated heparin at a dose of 10,000 in 4 ml of 0.9% saline IU/6 h daily for 7 days via ventilator circuit.

Treatment:

Drug: nebulization

hypertonic saline

Active Comparator group

Description:

This group will receive inhaled hypertonic saline 3% in a dose of 4ml /6 h daily for 7 days.

Treatment:

Drug: nebulization

control

Placebo Comparator group

Description:

This group will receive inhaled normal saline 0.9 % in a dose of 4ml /6 h daily for 7 days.

Treatment:

Drug: nebulization