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Inhaled Prostacyclin for Adult Respiratory Distress Syndrome (ARDS) and Pulmonary Hypertension

This study has been completed.
Sponsor:
Collaborator:
Medical Research Council, Pakistan
Information provided by:
Aga Khan University
ClinicalTrials.gov Identifier:
NCT00314548
First received: April 12, 2006
Last updated: May 18, 2010
Last verified: November 2009
History of Changes
  Purpose

Summary of the proposed research:

The intravenous application of prostacyclin (PGE1) or its stable analogue, iloprost, has been used to cause a decrease not only of the pulmonary but also of the systemic vascular tone. Aerosolized prostacyclin, on the other hand, can result in a selective pulmonary vasodilatation without affecting the systemic blood pressure as shown in preliminary studies/case reports. No large trials exist for this type of use of the drug so far. Furthermore, aerosolized PGI2 can improve gas exchange and pulmonary shunt in clinical settings of impaired ventilation/perfusion ratio as it occurs in adult respiratory distress syndrome (ARDS) due to the redistribution of pulmonary blood flow from non-ventilated to ventilated, aerosol accessible lung regions. Therefore, the investigators propose to carry out a prospective, double blinded, randomized trial to show that the nebulized iloprost decreases pulmonary hypertension selectively and improves oxygenation in ARDS.


Condition Intervention
Adult Respiratory Distress Syndrome
Pulmonary Hypertension
 Drug: PGE1 (prostacyclin)
Drug: normal saline

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Trial of Inhaled Alprostadil to Improve Hypoxia and Pulmonary Hypertension

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Aga Khan University:

Primary Outcome Measures:
  • PaO2/FiO2 ratio increases by 10 [ Time Frame: 30 mins ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • PA [pulmonary artery] pressures decrease by 10 mm Hg [ Time Frame: 30 mins ] [ Designated as safety issue: No ]

Enrollment: 67
Study Start Date: May 2006
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cases
PGE1 drug
 Drug: PGE1 (prostacyclin)
alprostadil nebulization
Other Name: alprostadil
Placebo Comparator: Placebo
normal saline via same nebulizer
 Drug: normal saline
nebulize for 30 mins
Other Name: normal saline

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

After obtaining informed consent the following patients will be included:

  • All patients admitted to the ICU with pulmonary hypertension (mean PA > 35 mmHg).
  • All patients in ICU with post operative pulmonary HTN (mean PA > 35 mm Hg).
  • All patients with ARDS (PaO2/FiO2 < 200 - arterial hypoxemia, bilateral infiltrates on Chest X-ray infiltrates on CXR and a wedge < 20 mm Hg on swan ganz parameters) or signs of heart failure.

Exclusion Criteria:

Patients to be excluded will be those with:

  • Pulmonary embolus.
  • Cor pulmonale.
  • Ejection fraction of < 30%, wedge > 20 mm Hg.
  • Non-intubated patients.
  • Pediatric patients (< 16 yrs of age).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00314548

Sponsors and Collaborators
Aga Khan University
Medical Research Council, Pakistan
Investigators
Principal Investigator: Shahla Siddiqui, MBBS, DABA Aga Khan University
  More Information

Publications:
1. Domenighetti G, Stricker H. et al. Nebulized prostacyclin in ARDS: impact of primary and secondary disease on gas exchange response. Crit Care Med. 2001 ;29 (1) :57-62 2. Macherndl S, Kneussl M. et al. Long term treatment of pulmonary hypertension with aerosolized iloprost. Eur Respir J. 2001; 17(1): 8-13 3. Max M, Rossaint R. Inhaled prostacyclin in the treatment of pulmonary hypertension. Eur J Pediatr. 1999; 158 supp 1: S23-6. 4. Hoeper M, Olschewski H.et al. A comparison of the acute hemodynamic effects of inhaled nitric oxide and aerosolized iloprost in primary pulmonary hypertension. German PPH study group. J AM Coll Card. 2000 ; 35(1):176-82. 5. Olschewski h, Ghofrani H. et al. Inhaled iloprost to treat severe pulmonary hypertension. An uncontrolled trial. German PPH study group. Ann Int Med. 2000 21;132 (6):435-43.

Responsible Party: Dr. Shahla Siddiqui, Aga Khan University/Pakistan Medical Research Council
ClinicalTrials.gov Identifier: NCT00314548     History of Changes
Other Study ID Numbers: 4-22-3/05/RDC/AKU/3479
Study First Received: April 12, 2006
Last Updated: May 18, 2010
Health Authority: Pakistan: Research Ethics Committee

Keywords provided by Aga Khan University:
ARDS
pulmonary hypertension
prostacyclins

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury
 Alprostadil
Epoprostenol
Tezosentan
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Vasodilator Agents
Cardiovascular Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents

ClinicalTrials.gov processed this record on May 21, 2013