TerminatedPhase 2

Treprostinil Sodium Inhalation for Patients At High Risk for ARDS

United States14 participantsStarted 2015-02

Plain-language summary

Acute Respiratory Distress Syndrome (ARDS) is a rapidly progressing lung disease caused by a number of factors including pneumonia, sepsis and acute trauma that leads to reduced lung function and breathlessness. There are no pharmacological treatments approved for the treatment of ARDS. This pilot trial will study the safety and efficacy of Treprostinil sodium by inhalation for preventing the progression of acute hypoxemic respiratory failure to positive pressure ventilation and/or ARDS in patients at high risk.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. Adults age 18-75 years.
✓. Acute onset need for 4 liters per minute (LPM) or more of supplemental oxygen to maintain Arterial partial pressure of oxygen (PaO2) \> 60 mmHg or arterial O2 saturation \> 90% by pulse oximetry.

Exclusion criteria

✕. No consent/inability to obtain consent
✕. Presence of pulmonary embolism
✕. Known diffuse alveolar hemorrhage from vasculitis
✕. Known pre-existing severe obstructive or restrictive lung disease (FEV 1 \< 40% predicted, total lung capacity (TLC) \< 50 % predicted) or need for long-term supplemental oxygen therapy
✕. Known significant left ventricular systolic dysfunction with left ventricular ejection fraction (LVEF) \< 45% on echocardiogram.
✕. Mean arterial pressure \< 65 mmHg
✕. Need for norepinephrine or dopamine dose \> 12 mcg to maintain mean arterial pressure (MAP) \> 65 mmHg
✕. Severe chronic liver disease (Child-Pugh Score 11-15)

What they're measuring

Change in the Ratio of the Partial Pressure of Arterial Oxygen to the Fraction of Inspired Oxygen (PaO2/FiO2 Ratio)

Timeframe: Change in PaO2/FiO2 ratio from day 0 to day 2.

Trial details

NCT IDNCT02370095

SponsorUniversity of North Carolina, Chapel Hill

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-10-11

Results submitted2019-08-09

View on ClinicalTrials.gov More Respiratory Distress Syndrome, Adult trials