Effect of Inhaled Nitric Oxide Therapy in Adults With Moderate-to-Severe Acute Respiratory Distress Syndrome

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

ARDS (Moderate or Severe) Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age ≥ 18 years.
Patients diagnosed with moderate-to-severe ARDS according to the 2023 Global (or international) criteria.

Exclusion criteria

Known allergy to iNO.
Congenital methemoglobinemia.
End-stage chronic lung disease (e.g., lung cancer, prior pneumonectomy/lung transplant).
Shock (norepinephrine >0.5 μg/kg/min or equivalent for >6 hours) at treatment initiation.
Pulmonary hypertension (PASP >45 mmHg by echo or mPAP ≥25 mmHg by catheterization).
Serum creatinine >2.5 mg/dL (221 μmol/L).
Major bleeding (e.g., intracranial, pulmonary) or platelet count <20×10⁹/L.
Expected ICU/mechanical ventilation <24 hours.
Pre-enrollment ECMO therapy.
Any investigator-assessed unsuitability for the study.

Treatment and study plan

Inhaled Nitric Oxide Therapy

Procedure

Patients randomized to the intervention group will receive inhaled nitric oxide (iNO) delivered via the portable INOwill N200 system in addition to standard ARDS care. iNO administration will commence immediately upon enrollment, with its concentration set and titrated in accordance with established clinical practice guidelines.

Primary outcomes

28-day mortality

Time frame: within 28 days after randomization

The primary outcome was 28-day all-cause mortality, defined as death from any cause occurring within 28 days following randomization. All patients must be followed up through day 28, regardless of hospital discharge status.

Sponsors and collaborators

Lead sponsor

Nanfang Hospital, Southern Medical University

Other

Registry information

Official study title

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)

Acronym: ENARCT-ARDS

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: Jan 12, 2026
Registry last updated: Jan 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Not Yet Recruiting