- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01274481
Iloprost Effects on Gas Exchange and Pulmonary Mechanics
Effect of Iloprost on Gas Exchange and Pulmonary Mechanics in Patients With Pulmonary Hypertension and ARDS/ALI
Study Overview
Status
Intervention / Treatment
Detailed Description
Purpose/hypothesis 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.
Experimental design Twenty patients with pulmonary hypertension and ARDS/ALI will be enrolled. This will be 2-3 hour study conducted on a single day in which each patient's baseline measurements obtained prior to iloprost administration are compared to measurements obtained 30 minutes and 2 hours after Iloprost inhalation. While critically ill by virtue of their underlying illness, patients will be clinically stable over the preceding 2 hours prior to entry into the study as evidenced by airway pressures and arterial O2 saturation that vary less than 10% on the same ventilator settings.
Proposed procedure After baseline measurements are obtained, 10 mcg iloprost will be administered via nebulizer on the inspiratory line of the ventilator. Vital signs including blood pressure and heart rate, respiratory rate and arterial saturation by pulse oximetry will be monitored at baseline and q 5 minutes after the inhalation of iloprost. Thirty (30) minutes after the administration of iloprost the gas exchange, pulmonary function and arterial blood gas measurements will be repeated as described above. Patients who remain clinically stable as evidenced by a fall in arterial PO2 <5 mm Hg, fall in systemic blood pressure of <10% and increase in heart rate of <10 beats/min as well as the absence of symptoms 30 minutes after the inhalation of 20 mcg of iloprost will receive a second dose of 20 mcg. Vital signs will continue to be monitored continuously and 30 minutes after the second dose of iloprost, all pulmonary measurements will be repeated. All patients will be monitored continuously for at least 2 hours after the final dose of iloprost and pulmonary testing will be repeated for a final time 2 hours after the last administration of iloprost. Patients will be deemed to have completed the study after 2 hours provided their vital signs have returned to within 10% of baseline values.
Importance of knowledge reasonably expected to result from the research A positive result in this pilot study will provide a strong rationale leading to a larger long-term study examining the effect of continuous iloprost therapy over several days on pulmonary hemodynamics, gas exchange, and outcome in patients with ARDS/ALI. Markers of inflammation (IL-6 and IL-8), coagulation (thrombin-antithrombin complexes and D-dimer) and collagen formation (TGF* and procollagen peptide III) in lung BAL fluid would be monitored to demonstrate iloprost's potential beneficial effects on lung remodeling in this devastating disorder.
If the research involves more than minimal risk, describe the research plan for monitoring the data collected to ensure the safety of participants.
Data safety monitoring board will meet after the first six patients and determine whether to continue.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Oklahoma
-
Oklahoma City, Oklahoma, United States, 73104
- OU Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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.
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
- presence of an arterial line for pressure monitoring and blood sampling, and
- the ability to obtain informed consent from the patient or next of kin.
Exclusion Criteria:
- clinical instability as evidenced by changes in ventilator settings or medications within the preceding hour, and
- presence of left ventricular dysfunction and/or left atrial enlargement by cardiac echo, or catheterization,
- Liver failure (Child-Pugh Class B or C)
- Renal failure on dialysis
- Pregnancy: all females of child-bearing potential will have a negative pregnancy test before being allowed to enroll
- 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
- Thrombocytopenia, bleeding diathesis or active bleeding
- Asthma/Severe bronchospasm
- Age < 18 years
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Iloprost
All patients will have their response to Iloprost compared to baseline pre-treatment.
|
patients inhale 20 mcg of Iloprost via nebulizer and, if oxygenation and blood pressure is maintained receive a second dose of 20 mcg of Iloprost 30 minutes later.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Arterial oxygenation
Time Frame: 30 minutes
|
30 minutes
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Lung compliance
Time Frame: 30 minutes
|
30 minutes
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Respiratory Tract Diseases
- Respiration Disorders
- Lung Diseases
- Wounds and Injuries
- Infant, Newborn, Diseases
- Infant, Premature, Diseases
- Thoracic Injuries
- Hypertension
- Hypertension, Pulmonary
- Respiratory Distress Syndrome
- Respiratory Distress Syndrome, Newborn
- Acute Lung Injury
- Lung Injury
- Vasodilator Agents
- Platelet Aggregation Inhibitors
- Iloprost
Other Study ID Numbers
- 15123
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pulmonary Hypertension
-
Centre Chirurgical Marie LannelongueUnknownChronic Thrombo-embolic Pulmonary Hypertension and Pulmonary Arterial HypertensionFrance
-
Sheffield Teaching Hospitals NHS Foundation TrustUniversity of SheffieldCompletedIdiopathic Pulmonary Arterial Hypertension | Chronic Thromboembolic Pulmonary HypertensionUnited Kingdom
-
Heidelberg UniversityMerck Sharp & Dohme LLCRecruitingChronic Thromboembolic Pulmonary Hypertension | Primary Pulmonary Arterial HypertensionGermany
-
University of South FloridaWithdrawnPulmonary Arterial Hypertension | Familial Primary Pulmonary Hypertension | Idiopathic Pulmonary Arterial Hypertension | Primary Pulmonary HypertensionUnited States
-
BayerCompletedPrimary HypertensionChina
-
University of Kansas Medical CenterRecruitingPulmonary Arterial Hypertension | Pulmonary Hypertension | Chronic Thromboembolic Pulmonary Hypertension | Pulmonary Hypertension Due to Left Heart Disease | Pulmonary Hypertension, Primary, 4 | Pulmonary Hypertension, Primary, 2 | Pulmonary Hypertension, Primary, 3 | Pulmonary Hypertension, Primary and other conditionsUnited States
-
Vanderbilt University Medical CenterJohns Hopkins UniversityCompletedPulmonary Arterial Hypertension | Idiopathic Pulmonary Arterial Hypertension | Associated Pulmonary Arterial Hypertension | Heritable Pulmonary Arterial HypertensionUnited States
-
Papworth Hospital NHS Foundation TrustMerck Sharp & Dohme LLCCompleted
-
University of ZurichCompletedPulmonary Hypertension | Pulmonary Artery Hypertension | Chronic Thromboembolic Pulmonary HypertensionSwitzerland
-
National Taiwan University HospitalUnknownPulmonary HypertensionTaiwan
Clinical Trials on Iloprost
-
University of OklahomaCompletedChronic Obstructive Pulmonary Disease | Pulmonary HypertensionUnited States
-
Charite University, Berlin, GermanySchering-PloughTerminatedSystemic SclerosisGermany
-
ActelionTerminatedPulmonary Arterial HypertensionUnited States
-
ActelionTerminatedPulmonary HypertensionUnited States
-
Loma Linda UniversityWithdrawnHypoxic Pulmonary VasoconstrictionUnited States
-
National Center for Research Resources (NCRR)University of PittsburghCompletedSystemic Sclerosis | Raynaud Disease
-
Lund University HospitalBayerWithdrawnRespiratory Distress Syndrome | Persistent Pulmonary HypertensionSweden
-
University of Colorado, DenverNational Cancer Institute (NCI)CompletedLung Cancer | Precancerous ConditionUnited States
-
BayerCompletedHypertension, PulmonaryItaly, Spain, France, Germany, Portugal, United Kingdom
-
University of ChicagoTerminatedPulmonary HypertensionIsrael, United States