Inhaled Nitric Oxide for ARDS-related Pulmonary Hypertension

Yuri Matusov

Status and phase: Not yet enrolling; Early Phase 1

Conditions: Acute Respiratory Distress Syndrome; Pulmonary Hypertension

Treatments: Drug: Nitric Oxide

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06249633

STUDY00001807

Details and patient eligibility

About

Open-label pilot study of early inhaled nitric oxide (iNO) for patients developing de novo pulmonary hypertension during Acute Respiratory Distress Syndrome (ARDS.) The study aims to determine whether iNO has possible hemodynamic and clinical benefits when given early in the course of ARDS to patients with evidence of elevated pulmonary artery pressure.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of ARDS based on the Berlin criteria
• Mechanically ventilated
• Age ≥ 18 years

Exclusion criteria

• Primary cardiogenic shock
• History of more than mild pulmonary hypertension preceding ARDS diagnosis
• Presence of pre-existing significant valvular disease
• Presence of pre-existing left ventricular dysfunction or significant hypertrophy
• Consent cannot be obtained from the patient or his/her surrogates
• Refusal of consent
• Opinion of treating physicians that enrolling the patient in the study would be detrimental to his/her outcome

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

iNOMAX

Experimental group

Treatment:

Drug: Nitric Oxide