Could a common steroid save lives in severe lung failure?
NCT ID NCT07576660
First seen Jun 27, 2026 · Last updated Sep 03, 2026 · Updated 4 times
Summary
This study tests whether the steroid dexamethasone, when added to standard care, can lower the chance of death within 90 days for people with a serious lung condition called ARDS caused by sepsis. About 1,474 adults on breathing machines will take part. The goal is to see if this anti-inflammatory drug helps more people survive.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 1,704 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2026
- Expected to finish
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Sep 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age 18 years or older 2. Suspected or confirmed infection 3. Receipt of invasive mechanical ventilation with a positive end-expiratory pressure (PEEP) of at least 5 cm H₂O, noninvasive positive-pressure ventilation with a PEEP of at least 5 cm H₂O, or high-flow nasal oxygen therapy with a flow rate of at least 30 L/min 4. Acute-onset ARDS, defined as ARDS diagnosed for at least 6 hours but no more than 72 hours, according to the following criteria: (1) New or worsening respiratory symptoms or respiratory failure (2) Pulmonary infiltrates on chest radiography or computed tomography, or B-lines or consolidation on lung ultrasonography, not fully explained by pleural effusion, lobar or whole-lung collapse or atelectasis, or pulmonary nodules. Patients with unilateral pulmonary infiltrates, B-lines, or consolidation are eligible (3) Respiratory failure not fully explained by cardiac failure or fluid overload (4) Hypoxemia defined as PaO₂/FiO₂ of 300 mm Hg or less, or SpO₂/FiO₂ of 315 or less, with SpO₂ no greater than 97%. Exclusion Criteria: 1. Pregnancy 2. Planned withdrawal of life-sustaining treatment within the next 24 hours 3. Current hospitalization for more than 7 days before screening; 4. Clinical improvement within the 48 hours before randomization, based on the investigator's overall assessment 5. Highly suspected or confirmed COVID-19 infection 6. Severe chronic obstructive pulmonary disease, defined as a PaCO₂ ≥ 60 mmHg in a stable condition, or the need for long-term oxygen therapy, excluding CPAP/BiPAP prescribed exclusively for sleep-disordered breathing. 7. Congestive heart failure (NYHA III-IV) 8. A definite clinical indication for high-dose corticosteroids at screening, defined as a maximum daily dose exceeding hydrocortisone 200 mg or an equivalent glucocorticoid dose 9. Contraindications to short-term dexamethasone, including untreated systemic fungal infection, active tuberculosis, active viral hepatitis, or major upper gastrointestinal bleeding 10. Known hypersensitivity to dexamethasone 11. Participation in another interventional clinical trial within the previous 30 days
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Zhongda Hospital, School of Medicine, Southeast University
NOT_YET_RECRUITINGNanjing, Jiangsu, 210009, China
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Zhongda Hospital, School of Medicine, Southeast University
RECRUITINGNanjing, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can Real-Time lung imaging Fine-Tune ventilator care for ARDS?
- Can tailored breathing support and early muscle relaxants boost survival in ARDS?
- Immune clues may unlock better ECMO care for lung failure patients
- New study aims to Fine-Tune ventilator strategies for ARDS patients
- Can the right dose and timing of steroids save more lives in ARDS?
- New inflatable cushion could revolutionize ICU patient repositioning