Inhaled Nitric Oxide for ARDS-related Pulmonary Hypertension

January 31, 2024 updated by: Yuri Matusov

A Pilot Study of Inhaled Nitric Oxide for ARDS-related Pulmonary Hypertension

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90048

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: iNOMAX
Drug: Nitric Oxide
Inhaled nitric oxide
Other Names:
  • iNOMAX

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in urine output in response to iNO
Time Frame: 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.
Approximately 4 days
Improvement in serum creatinine in response to iNO
Time Frame: Approximately 4 days
Changes in serum creatinine (in mg/dL) will be determined by laboratory analysis following initiation of iNO.
Approximately 4 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yuri Matusov

Collaborators

Mallinckrodt

Investigators

  • Principal Investigator: Yuri Matusov, MD, Cedars-Sinai Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2024

Primary Completion (Estimated)

February 1, 2026

Study Completion (Estimated)

February 1, 2026

Study Registration Dates

First Submitted

January 12, 2024

First Submitted That Met QC Criteria

January 31, 2024

First Posted (Actual)

February 8, 2024

Study Record Updates

Last Update Posted (Actual)

February 8, 2024

Last Update Submitted That Met QC Criteria

January 31, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00001807

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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