Inhaled Nitric Oxide for ARDS-related Pulmonary Hypertension

NCT ID: NCT06249633

Last Updated: 2024-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-29

Study Completion Date

2026-02-28

Brief Summary

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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

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Conditions

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Acute Respiratory Distress Syndrome Pulmonary Hypertension

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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iNOMAX

Group Type EXPERIMENTAL

Nitric Oxide

Intervention Type DRUG

Inhaled nitric oxide

Interventions

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Nitric Oxide

Inhaled nitric oxide

Intervention Type DRUG

Other Intervention Names

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iNOMAX

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mallinckrodt

INDUSTRY

Sponsor Role collaborator

Yuri Matusov

OTHER

Sponsor Role lead

Responsible Party

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Yuri Matusov

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Yuri Matusov, MD

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinai Medical Center

Locations

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Cedars-Sinai Medical Center

Los Angeles, California, United States

Site Status

Countries

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United States

Central Contacts

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Emine Gholian

Role: CONTACT

310-423-8474

Facility Contacts

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Emine Gholian

Role: primary

Other Identifiers

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STUDY00001807

Identifier Type: -

Identifier Source: org_study_id

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