Acute Respiratory Distress SyndromePhase 1NCT01274481
Iloprost Effects on Gas Exchange and Pulmonary Mechanics
A Phase 1 study testing Iloprost in people with Acute Respiratory Distress Syndrome and Acute Lung Injury, run by University of Oklahoma at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome, Acute Lung Injury, Pulmonary Hypertension
- What is being tested?
- Iloprost
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Jul 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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
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- Thrombocytopenia, bleeding diathesis or active bleeding
- Asthma/Severe bronchospasm
- Age < 18 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Iloprost on Gas Exchange and Pulmonary Mechanics in Patients With Pulmonary Hypertension and ARDS/ALI
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.
Read the 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.
- Being tested
- Iloprost
- Keywords
- Acute Respiratory Distress Syndrome, Acute Lung Injury, pulmonary hypertension, oxygenation, lung mechanics, gas exchange
- Medical subject headings
- Respiratory Distress Syndrome, Acute Lung Injury, Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IloprostDrug
Also called Ventavis
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.
| Study group | Role | What they receive |
|---|---|---|
| Iloprost | Experimental | All patients will have their response to Iloprost compared to baseline pre-treatment. Receives: Drug: Iloprost |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arterial oxygenation
Measured: 30 minutes
Secondary outcomes (1)
Lung compliance
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2011 (estimated)
- Study startMar 2011
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Collaborators
- Actelion
- Responsible party
- Principal investigator, Gary Kinasewitz, University of Oklahoma
- Investigators
- Gary Kinasewitz, MD, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01274481
- Sponsor's protocol ID
- 15123
- Status last verified
- Aug 2012
- First submitted
- 15 Nov 2010
- Last updated
- 10 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sawheny E, Ellis AL, Kinasewitz GT. Iloprost improves gas exchange in patients with pulmonary hypertension and ARDS. Chest. 2013 Jul;144(1):55-62. doi: 10.1378/chest.12-2296.
PubMed 23370599
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Iloprost on Gas Exchange and Pulmonary Mechanics in Patients With Pulmonary Hypertension and ARDS/ALI
- ClinicalTrials.gov ID
- NCT01274481
- Acronym / sponsor ID
- 15123
- Keywords
- Acute Respiratory Distress Syndrome, Acute Lung Injury, pulmonary hypertension, oxygenation, lung mechanics, gas exchange
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Collaborators
- Actelion
- Study start
- Mar 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 11 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Iloprost | Experimental | Drug: IloprostAll patients will have their response to Iloprost compared to baseline pre-treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Pulmonary hypertension as evidenced by:
- ARDS/ALI as indicated by:
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IloprostAlso: Ventavispatients 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. | Drug | Iloprost |
Primary outcome
Arterial oxygenation
Time frame: 30 minutes
1 secondary outcome
Lung compliance
Time frame: 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2012.
- Derived from this study: PubMed 23370599Sawheny E, Ellis AL, Kinasewitz GT. Iloprost improves gas exchange in patients with pulmonary hypertension and ARDS. Chest. 2013 Jul;144(1):55-62. doi: 10.1378/chest.12-2296.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gary Kinasewitz, MD principal investigator
University of Oklahoma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Iloprost in people with Acute Respiratory Distress Syndrome and Acute Lung Injury, run by University of Oklahoma at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arterial oxygenation (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01274481, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2012.