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Trial record 52 of 61 for:    "Lung Disease" | "Iloprost"

Iloprost Effects on Gas Exchange and Pulmonary Mechanics

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ClinicalTrials.gov Identifier: NCT01274481
Recruitment Status : Completed
First Posted : January 11, 2011
Last Update Posted : August 10, 2012
Sponsor:
Collaborator:
Actelion
Information provided by (Responsible Party):
Gary Kinasewitz, University of Oklahoma

Tracking Information
First Submitted Date  ICMJE November 15, 2010
First Posted Date  ICMJE January 11, 2011
Last Update Posted Date August 10, 2012
Study Start Date  ICMJE March 2011
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 10, 2011)
Arterial oxygenation [ Time Frame: 30 minutes ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01274481 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 10, 2011)
Lung compliance [ Time Frame: 30 minutes ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Iloprost Effects on Gas Exchange and Pulmonary Mechanics
Official Title  ICMJE Effect of Iloprost on Gas Exchange and Pulmonary Mechanics in Patients With Pulmonary Hypertension and ARDS/ALI
Brief 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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Acute Respiratory Distress Syndrome
  • Acute Lung Injury
  • Pulmonary Hypertension
Intervention  ICMJE Drug: Iloprost
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 Name: Ventavis
Study Arms  ICMJE Experimental: Iloprost
All patients will have their response to Iloprost compared to baseline pre-treatment.
Intervention: Drug: Iloprost
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 10, 2011)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2012
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01274481
Other Study ID Numbers  ICMJE 15123
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gary Kinasewitz, University of Oklahoma
Study Sponsor  ICMJE University of Oklahoma
Collaborators  ICMJE Actelion
Investigators  ICMJE
Principal Investigator: Gary Kinasewitz, MD University of Oklahoma
PRS Account University of Oklahoma
Verification Date August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP