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Inhaled Nitric Oxide for the Treatment of Adults with Moderate-to-Severe ARDS: A Multicenter Clinical Trial

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)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500115555
Enrollment
Unknown
Registered
2025-12-29
Start date
2025-12-31
Completion date
Unknown
Last updated
2026-01-05

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

Conditions

Moderate to severe acute respiratory distress syndrome

Interventions

Control group:standard of care for ARDS

Sponsors

Southern Medical University Southern Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Voluntary signing of the informed consent form; 2. Age > 18 years old; 3. Diagnosed as moderate to severe ARDS patients requiring endotracheal intubation or not requiring endotracheal intubation, in accordance with the 2023 Global ARDS standards issued by AAJRCCM.

Exclusion criteria

Exclusion criteria: 1. Known to be allergic to iNO 2. Congenital hyperbilirubinemia 3. End-stage chronic lung diseases, including lung malignancies, lung resection, and lung transplantation history 4. Patients with shock or hemodynamic instability at the start of treatment (norepinephrine dose exceeding 0.5 µg/kg/min for 6 hours or more than the equivalent dose of other vasoactive drugs) 5. Measured pulmonary artery systolic pressure (PAP) > 45 mmHg by transthoracic echocardiography-Doppler or mPAP >=25 mmHg determined by right heart catheterization 6. ICU stay/ mechanical ventilation time less than 24 hours 7. Serum creatinine value > 2.5 mg/L (221 mmol/L) 8. Severe bleeding, such as intracranial hemorrhage, intraventricular hemorrhage, pulmonary hemorrhage, or platelet count < 20 x 10^9/L 9. Previously received extracorporeal membrane oxygenation treatment 10. Judged by the investigator to be unsuitable for participation in this study.

Design outcomes

Primary

MeasureTime frame
28-day all-cause mortality;

Secondary

MeasureTime frame
PaO2 / FiO2 index;Serum creatinine;

Countries

China

Contacts

Public ContactZhenhua Zeng

Southern Medical University Southern Hospital

zhenhuazeng.2008@163.com+86 15692428912

Outcome results

None listed

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