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| Name | Class |
|---|---|
| Mallinckrodt | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| iNOMAX | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nitric Oxide | Drug | Inhaled nitric oxide |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Determining improvement in pulmonary artery pressure in response to iNO | 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 | 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 | Changes in right ventricular fractional area change (in %) will be determined by repeat echocardiography after initiation of iNO. | Approximately 4 days |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in urine output in response to iNO | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emine Gholian | Contact | 310-423-8474 | grouplungresearch@cshs.org |
| Name | Affiliation | Role |
|---|---|---|
| Yuri Matusov, MD | Cedars-Sinai Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States |
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| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| D006976 | Hypertension, Pulmonary |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D006973 | Hypertension |
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| ID | Term |
|---|---|
| D009569 | Nitric Oxide |
| D045462 | Endothelium-Dependent Relaxing Factors |
| ID | Term |
|---|---|
| D026361 | Reactive Nitrogen Species |
| D005609 | Free Radicals |
| D007287 | Inorganic Chemicals |
| D009589 | Nitrogen Oxides |
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Changes in serum creatinine (in mg/dL) will be determined by laboratory analysis following initiation of iNO. |
| Approximately 4 days |
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D017672 |
| Nitrogen Compounds |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
| D009930 | Organic Chemicals |
| D014665 | Vasodilator Agents |
| D002317 | Cardiovascular Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |