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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00314548
Recruitment Status : Completed
First Posted : April 14, 2006
Last Update Posted : May 19, 2010
Medical Research Council, Pakistan
Information provided by:
Aga Khan University

Brief Summary:

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 or disease Intervention/treatment Phase
Adult Respiratory Distress Syndrome Pulmonary Hypertension Drug: PGE1 (prostacyclin) Drug: normal saline Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Trial of Inhaled Alprostadil to Improve Hypoxia and Pulmonary Hypertension
Study Start Date : May 2006
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. PaO2/FiO2 ratio increases by 10 [ Time Frame: 30 mins ]

Secondary Outcome Measures :
  1. PA [pulmonary artery] pressures decrease by 10 mm Hg [ Time Frame: 30 mins ]

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00314548

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

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Responsible Party: Dr. Shahla Siddiqui, Aga Khan University/Pakistan Medical Research Council Identifier: NCT00314548    
Other Study ID Numbers: 4-22-3/05/RDC/AKU/3479
First Posted: April 14, 2006    Key Record Dates
Last Update Posted: May 19, 2010
Last Verified: November 2009
Keywords provided by Aga Khan University:
pulmonary hypertension
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury
Platelet Aggregation Inhibitors
Vasodilator Agents
Urological Agents
Antihypertensive Agents