NCT07334873Not yet recruiting
Effect of Inhaled Nitric Oxide Therapy in Adults With Moderate-to-Severe Acute Respiratory Distress Syndrome
Evaluation of the Efficacy of Inhaled Nitric Oxide Therapy in Patients With Moderate to Severe Acute Respiratory Distress Syndrome: A Multicenter, Prospective, Randomized Controlled Clinical Trial (ENARCT-ARDS)
Source: ClinicalTrials.gov · Last updated 13 Jan 2026
Brief summary (registry, in English)
The goal of this clinical trial is to evaluate whether inhaled nitric oxide (iNO), added to standard care, can reduce mortality in adults with moderate-to-severe Acute Respiratory Distress Syndrome (ARDS). The main questions it aims to answer are: Does iNO therapy reduce 28-day all-cause mortality compared to standard care alone? Does iNO therapy increase the number of ventilator-free days through day 28? If there is a comparison group: Researchers will compare the group receiving iNO plus standard care with the group receiving placebo plus standard care to see if iNO improves survival and other clinical outcomes. Participants will: Be randomly assigned to receive either iNO or a placebo through the ventilator. Receive all other standard treatments for ARDS as per current guidelines. Be closely monitored for 28 days to track survival, time on the ventilator, and safety.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 536 (estimated)
- First submitted
- 31 Dec 2025
- Start date
- Jan 2026
- Primary completion date
- Dec 2027
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- NCT number
- NCT07334873
What you commit to
- Study type: Interventional
- Planned participants: 536
- From Jan 2026 to the primary completion date, Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- End-stage chronic lung disease (e.g., lung cancer, prior pneumonectomy/lung transplant).
- Pre-enrollment ECMO therapy.
Other illness
- Known allergy to iNO.
- Pulmonary hypertension (PASP \>45 mmHg by echo or mPAP ≥25 mmHg by catheterization).
Lab values
- Serum creatinine \>2.5 mg/dL (221 μmol/L).
- Major bleeding (e.g., intracranial, pulmonary) or platelet count \<20×10⁹/L.
Other
- Congenital methemoglobinemia.
- Shock (norepinephrine \>0.5 μg/kg/min or equivalent for \>6 hours) at treatment initiation.
- Expected ICU/mechanical ventilation \<24 hours.
- Any investigator-assessed unsuitability for the study.
Who the study is looking for
- Age ≥ 18 years.
- Patients diagnosed with moderate-to-severe ARDS according to the 2023 Global (or international) criteria.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Nanfang Hospital, Southern Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.