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

N/ANot Yet RecruitingNCT07334873

Nanfang Hospital, Southern Medical University536 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

536

Conditions

ARDS (Moderate or Severe)

Interventions

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

28-day mortality

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.

Time frame: within 28 days after randomization