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

NCT07286409 | Not Yet Recruiting

• 1 other identifier: nebulized drugs in ARDS
• Study Type: interventional
• Target: 344
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mechanical Ventilation Complication; Respiratory Distress Syndrome

Outcome Measures

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

  in the morning of 7 days of mechanical ventillation

Study Arms (4)

frusemide

ACTIVE COMPARATOR

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

Drug: nebulization

heparin

ACTIVE COMPARATOR

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.

Drug: nebulization

hypertonic saline

ACTIVE COMPARATOR

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

Drug: nebulization

control

PLACEBO COMPARATOR

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

Drug: nebulization

Interventions

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.

control; frusemide; heparin; hypertonic saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (≥18 years)
• ICU admission, mechanical ventilation for \< 7 days
• 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.

You may not qualify if:

• 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.
• Body Mass Index (BMI) \> 40 or severe obesity, which can severely impact lung mechanics and confound results.
• Electrolyte imbalance

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Faculty of medicine, Tanta university

Tanta, El Gharbyia, 31111, Egypt

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Central Study Contacts

tarek AH Mostafa

CONTACT

01003591332; dr.tarek311@yahoo.com

sameh Ahmed

CONTACT

samehabdelkhalik1982@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: December 16, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: December 16, 2025

Record last verified: 2025-12

Locations

EG (1)