Inhaled Nitric Oxide for ARDS-related Pulmonary Hypertension

Early Phase 1

Not yet recruiting

• Conditions: Acute Respiratory Distress Syndrome; Pulmonary Hypertension
• Interventions: Drug: Nitric Oxide

• Registration Number: NCT06249633
• Lead Sponsor: Yuri Matusov

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-01
• Study First Submitted: 2024-01-12
• Study First Submitted QC: 2024-01-31
• Last Update Submitted: 2024-01-31
• Study Start: 2024-02
• Study First Posted: 2024-02-08
• Last Update Posted: 2024-02-08
• Primary Completion: 2026-02
• Study Completion: 2026-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
iNOMAX	Nitric Oxide	-

Primary Outcome Measures

Name	Time	Method
Determining improvement in pulmonary artery pressure in response to iNO	Approximately 4 days	Pulmonary artery systolic pressure (in mmHg) will be determined by repeat echocardiography after initiation of iNO.
Determining improvement in tricuspid annular plane systolic excursion in response to iNO	Approximately 4 days	Changes in tricuspid annular plane systolic excursion (in cm) will be determined by repeat echocardiography after initiation of iNO.
Determining improvement in right ventricular fractional area change in response to iNO	Approximately 4 days	Changes in right ventricular fractional area change (in %) will be determined by repeat echocardiography after initiation of iNO.

Secondary Outcome Measures

Name	Time	Method
Improvement in serum creatinine in response to iNO	Approximately 4 days	Changes in serum creatinine (in mg/dL) will be determined by laboratory analysis following initiation of iNO.
Improvement in urine output in response to iNO	Approximately 4 days	Urine output changes will be determined by continuous bedside evaluation of urine output (in ml/hr) before and after initiation of iNO.

Trial Locations

Locations (1)

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States