Dexamethasone for sepsis-related ARDS in adults on ventilatory support

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, randomized, double-blind, placebo-controlled phase 3 trial enrolls adults with acute respiratory distress syndrome linked to suspected or confirmed infection who require invasive or noninvasive ventilation or high-flow therapy. Participants are randomly assigned to receive dexamethasone or placebo, with the goal of reducing inflammation and improving oxygenation and outcomes. The study builds on prior findings that glucocorticoids may improve ventilation duration and possibly survival, while addressing heterogeneity in ARDS causes. The trial emphasizes rigorous blinding and standardized criteria for ARDS onset, timing, and respiratory support. Results could influence standard care for ARDS when associated with infection.

Why it matters

Who can join: the full rules

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

Where it's running

• Zhongda Hospital, School of Medicine, Southeast University
  Nanjing, China Recruiting
• Zhongda Hospital, School of Medicine, Southeast University
  Nanjing, Jiangsu, China Not yet recruiting

Study contacts

• Principal investigator: Jianfeng Xie, MD — Southeast University, Zhongda Hospital
• Study coordinator: Hui Chen, MD
• Email: huichen.icu@gmail.com
• Phone: +86-18006138640

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Understanding immune patterns and ECMO strategies to help adults with severe ARDS

  This study tests how different immune and clinical patterns in adults with moderate-to-severe ARDS respond to ECMO and lung-protective care, aiming to improve outcomes.

  Recruiting at 16 sites Southeast University, China · Beijing, Beijing Municipality and 38 other locations · NCT07726940

• Optimal corticosteroid dosing for ARDS: short vs. prolonged therapy

  This trial tests different corticosteroid doses and treatment lengths to see which helps adults with ARDS who are on ventilators.

  Recruiting Phase 4 National Taiwan University Hospital · Taipei · NCT07711964

• Lateral positioning to optimize breathing in adults after abdominal surgery with ARDS

  This study tests whether lying on the left or right side helps improve lung function in adults who developed ARDS after abdominal surgery, using a bedside imaging test to watch ventilation and blood flow while changing positions.

  Recruiting Ruijin Hospital · Shanghai · NCT07669558

• NIRS for EDResp: Which first helps hypoxemic adults best?

  This trial tests whether non-invasive ventilation with a mask (NIPPV) or high-flow nasal oxygen (HFNO) is more helpful for adults in the emergency department with acute hypoxemic respiratory failure.

  Recruiting at 9 sites Ohio State University · Tucson, Arizona and 8 other locations · NCT07558265

• Sodium bicarbonate with bedside electrical impedance tomography to map lung blood flow in ventilated adults

  This project will try whether a small sodium bicarbonate injection combined with bedside electrical impedance tomography can map lung blood flow in adults on mechanical ventilation, compared with hypertonic saline.

  Recruiting First Affiliated Hospital of Wannan Medical College · Wuhu, Anhui · NCT07542366

• How torso tilt and ventilator PEEP affect lung opening in ARDS

  This study will see if tilting the patient's torso and changing PEEP helps open more lung and improve breathing mechanics in adults with moderate to severe ARDS on a ventilator.

  Recruiting at 2 sites Zhongda Hospital · Nanjing, Jiangsu and 2 other locations · NCT07504731

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.