Inhaled Nitric Oxide for ARDS-related Pulmonary Hypertension

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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 Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06249633
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Early Phase 1
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Yuri Matusov
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Yuri Matusov, MD
Principal Investigator Affiliation	Cedars-Sinai Medical Center
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, Industry
Overall Status	Not yet recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Acute Respiratory Distress Syndrome, Pulmonary Hypertension

Arms & Interventions

Arms

Experimental: iNOMAX

Interventions

Drug: - Nitric Oxide

Inhaled nitric oxide

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Cedars-Sinai Medical Center, Los Angeles, California

Status

Address

Cedars-Sinai Medical Center

Los Angeles, California, 90048

Site Contact

Emine Gholian

grouplungresearch@cshs.org

310-423-8474