NCT00314548

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2006

Typical duration for not_applicable

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

April 12, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 14, 2006

Completed
17 days until next milestone

Study Start

First participant enrolled

May 1, 2006

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

May 19, 2010

Status Verified

November 1, 2009

Enrollment Period

3.2 years

First QC Date

April 12, 2006

Last Update Submit

May 18, 2010

Conditions

Adult Respiratory Distress SyndromePulmonary Hypertension

Keywords

ARDSpulmonary hypertensionprostacyclins

Outcome Measures

Primary Outcomes (1)

  • PaO2/FiO2 ratio increases by 10

    30 mins

Secondary Outcomes (1)

  • PA [pulmonary artery] pressures decrease by 10 mm Hg

    30 mins

Study Arms (2)

Cases

EXPERIMENTAL

PGE1 drug

Drug: PGE1 (prostacyclin)

Placebo

PLACEBO COMPARATOR

normal saline via same nebulizer

Drug: normal saline

Interventions

PGE1 (prostacyclin)DRUG

alprostadil nebulization

Also known as: alprostadil
Cases
normal salineDRUG

nebulize for 30 mins

Placebo

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    BACKGROUND

MeSH Terms

Conditions

Respiratory Distress SyndromeHypertension, Pulmonary

Interventions

AlprostadilEpoprostenolSaline Solution

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration DisordersHypertensionVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins EProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsFatty Acids, MonounsaturatedAutacoidsInflammation MediatorsBiological FactorsProstaglandins ICrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Shahla Siddiqui, MBBS, DABA

    Aga Khan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 12, 2006

First Posted

April 14, 2006

Study Start

May 1, 2006

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

May 19, 2010

Record last verified: 2009-11