NCT01274481

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Mar 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 15, 2010

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 11, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

August 10, 2012

Status Verified

August 1, 2012

Enrollment Period

1.3 years

First QC Date

November 15, 2010

Last Update Submit

August 8, 2012

Conditions

Acute Respiratory Distress SyndromeAcute Lung InjuryPulmonary Hypertension

Keywords

Acute Respiratory Distress SyndromeAcute Lung Injurypulmonary hypertensionoxygenationlung mechanicsgas exchange

Outcome Measures

Primary Outcomes (1)

  • Arterial oxygenation

    30 minutes

Secondary Outcomes (1)

  • Lung compliance

    30 minutes

Study Arms (1)

Iloprost

EXPERIMENTAL

All patients will have their response to Iloprost compared to baseline pre-treatment.

Drug: Iloprost

Interventions

IloprostDRUG

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.

Also known as: Ventavis
Iloprost

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

OU Medical Center

Oklahoma City, Oklahoma, 73104, United States

Location

Related Publications (1)

  • 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.

    PMID: 23370599DERIVED

MeSH Terms

Conditions

Respiratory Distress SyndromeAcute Lung InjuryHypertension, Pulmonary

Interventions

Iloprost

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration DisordersLung InjuryHypertensionVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • Gary Kinasewitz, MD

    University of Oklahoma

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 15, 2010

First Posted

January 11, 2011

Study Start

March 1, 2011

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

August 10, 2012

Record last verified: 2012-08

Locations

US(1)