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)

Status

Not yet recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07334873

Acronym

ENARCT-ARDS

Enrollment

536

Registered

2026-01-12

Start date

2026-01-31

Completion date

2027-12-31

Last updated

2026-01-13

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

Conditions

ARDS (Moderate or Severe)

Keywords

Inhaled Nitric Oxide Therapy, ARDS

Brief summary

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.

Interventions

PROCEDUREInhaled Nitric Oxide Therapy

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
28-day mortality	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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026