Iloprost Effects on Gas Exchange and Pulmonary Mechanics

• Status: Completed
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will examine the hypothesis that iloprost maintains and improves ventilation perfusion matching in patients with pulmonary hypertension and ARDS/ALI as reflected by 1) an improved PaO2/FIO2 ratio as calculated from the measured arterial blood gases obtained before and after iloprost administration, 2) an improvement in lung compliance, and 3) an improvement in the ventilatory equivalents for oxygen and CO2 measured by expired gas analysis.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Oklahoma
• Collaborator: Actelion
• Treatments: Iloprost

Criteria

Inclusion Criteria:

1. Pulmonary hypertension as evidenced by:

• In patients with a pulmonary artery catheter, a mean pulmonary arterial pressure greater then 25 mmHg with a pulmonary capillary wedge pressure less than or equal to 15 mmHg, or

• Echocardiographic evidence of pulmonary arterial hypertension including

• a PA systolic pressure greater than 35 mmHg, or

• in those patients in whom a PA systolic cannot be estimated for technical reasons, RV dilatation and/or decreased RV function in the presence of normal LV function.

2. ARDS/ALI as indicated by:

• Diffuse pulmonary infiltrates involving at least three of four quadrants on chest x-ray.

• PaO2/FIO2 less than 300 while on mechanical ventilation.

• Recognized cause of ARDS/ALI

• Absence of clinical evidence of left atrial hypertension

3. presence of an arterial line for pressure monitoring and blood sampling, and

4. the ability to obtain informed consent from the patient or next of kin.

Exclusion Criteria:

1. clinical instability as evidenced by changes in ventilator settings or medications within the preceding hour, and

2. presence of left ventricular dysfunction and/or left atrial enlargement by cardiac echo, or catheterization,

3. Liver failure (Child-Pugh Class B or C)

4. Renal failure on dialysis

5. Pregnancy: all females of child-bearing potential will have a negative pregnancy test before being allowed to enroll

6. Systolic blood pressure less than 85 mm Hg or the need for pressors in the first 10 patients; after review of the first 10 patients by the DMSB, patients on norepinephrine (without additional pressors) in doses less than 0.2 mcg/kg/min may be enrolled if the DMSB finds no evidence of iloprost induced systemic hypotension in the first 10 patients

7. Thrombocytopenia, bleeding diathesis or active bleeding

8. Asthma/Severe bronchospasm

9. Age < 18 years