Acute Respiratory Distress Syndrome, Pulmonary Hypertension
Conditions
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.
Interventions
DRUGNitric Oxide
Inhaled nitric oxide
Sponsors
Mallinckrodt
Yuri Matusov
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
United States
Contacts
Primary ContactEmine Gholian
Outcome results
None listed