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Can a nebulized medication reduce death rates in adults with severe lung failure on ventilators?

Effect of Nebulized Furosemide on Mortality of Adult Mechanically Ventilated ARDS Patients. Protocol of a Randomized Clinical Trial (ENHALE Trial)

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN16516753
Enrollment
784
Registered
2025-03-21
Start date
2025-04-01
Completion date
Unknown
Last updated
2025-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Treatment of mechancally ventlated adults wiith Acute Respratory Distress Syndrome (ARDS) Respiratory

Interventions

The intervention will be Nebulized Furosemide, in a dose of 40 mg furosemide in four ml of 0.9% saline, administered every six hours via the ventilator circuit over 30 minutes. The nebulization circu

Sponsors

King Saud Medical City
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Adults (=18 years). 2. ICU admission. 3. Mechanical ventilation for <7 days. 4. ARDS diagnosed within 24 hours per Berlin Definition, which includes: 4.1. Chest x-ray showing bilateral opacities, not fully explained by effusions, lobar/lung collapse, or nodules. 4.2. Respiratory failure not fully explained by cardiac failure or fluid overload, and exclusion of hydrostatic edema (by echocardiography). 4.3. Oxygenation and ventilator settings matching one of the three categories of ARDS: Mild: 200 mm Hg < PaO2/FIO2 = 300 mm Hg with PEEP or 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

Exclusion criteria: 1. Pregnant or lactating ladies. 2. Patients who are not expected to survive more than 48 hours, according to the treating team. 3. Mechanical ventilation is expected to continue for less than 48 hours (due to rapid recovery) according to the treating team. 4. Advanced directive of Do Not Resuscitate (DNR). 5. Refusal to participate in the trial by the patient, or official surrogate. 6. Known allergy to furosemide. 7. Previous enrollment in the trial (a patient can only be enrolled once).

Design outcomes

Primary

MeasureTime frame
28 day mortality measured using hospital records

Secondary

MeasureTime frame
1. All-cause hospital mortality is measured using hospital records at discharge 2. ICU length of stay (LOS) is measured using ICU records at discharge 3. Hospital length of stay (LOS) is measured using hospital records at discharge 4. Difference of P/F ratio is measured using arterial blood gas analysis at day one and day seven (not calculated for patients who are censored before seven days) 5. Ventilator-free days (VFD) is measured using ventilator records at 28 days 6. Successful extubation rate is measured using patient records at extubation 7. Hypersensitivity reactions of any magnitude are measured using patient reports and clinical assessments at any time during the study 8. Abnormal lab investigations, specifically electrolytes and renal function tests, are measured using blood tests at baseline and at regular intervals during the study 9. Volume of urine output is measured using urine output records at baseline and at regular intervals during the study

Countries

Saudi Arabia

Contacts

Public ContactWaleed Aletreby
wthashim@ksmc.med.sa+966 543531552

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026