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Inhaled Aerosolized Prostacyclin for Pulmonary Hypertension Requiring Inhaled Nitric Oxide

25 augustus 2014 bijgewerkt door: Duke University
Acute secondary pulmonary hypertension (PH) often leads to dysfunction of the right ventricle (RV) and can be a significant cause of patient morbidity and mortality. Selective pulmonary vasodilation with inhaled nitric oxide (INO) has become the treatment of choice for this condition. The evidence supporting INO safety and efficacy under these circumstances is sparse, however, and is largely extrapolated from the use of INO in neonatal pulmonary hypertension. Moreover, the high cost and potential toxicity of INO makes the therapy far from ideal. Emerging evidence suggests that inhaled aerosolized prostacyclins such as iloprost may be a favorable alternative therapy.

Studie Overzicht

Toestand

Beëindigd

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

Phase 1- In the original study, 3 doses of Iloprost were given. This was revised after 5 subjects were enrolled in order to study the effects of continuous delivery over a longer period of time.

Phase 2 - All remaining subjects received Iloprost as a continuous treatment.

The study was designed for an enrollment of 200 subjects and was ended early.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

27

Fase

  • Fase 4

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind
  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  1. Clinical evidence of pulmonary hypertension (PH) requiring INO therapy as prescribed by the attending physician.
  2. Indwelling arterial catheter.
  3. Signed informed consent

Exclusion Criteria:

  1. Clinically unstable circulatory condition requiring epinephrine > 0.1 mcg/kg/min or levophed, or already meeting treatment failure criteria (see section 5.3 below)
  2. Known hypersensitivity to prostacyclin compounds
  3. Patients receiving sildenafil or bosentan
  4. Refusal by the attending physician

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Crossover-opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Phase 2: Inhaled Iloprost continuous

Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.

A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized continuously at a dose of 5-30mcg/hour for as long as the attending physician deems it necessary to deliver vasodilator therapy.
Geneesmiddel: Inhaled Iloprost
A 20 mcg dose of Iloprost will be given initially.
Andere namen:
  • Ventavis
Experimenteel: Phase 1: Inhaled Iloprost 3 doses

Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.

A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized three different times on hour apart. Thirty minutes after the last iloprost dose, INO will be added back at the previous (baseline) dose.
Geneesmiddel: Inhaled Iloprost
A 20 mcg dose of Iloprost will be given initially.
Andere namen:
  • Ventavis

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Percent Change in Oxygen Saturation (SpO2) From Baseline
Tijdsspanne: 30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours
Readings were taken from the medical record and the data may not have been present at the exact time frames.
30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours
Percent Change in Oxygen Saturation (SpO2) From Baseline
Tijdsspanne: dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour)
dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour)
Change in Mean Heart Rate From Baseline
Tijdsspanne: 30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours
30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours
Change in Mean Heart Rate From Baseline
Tijdsspanne: dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour)
dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour)
Number of Treatment Failures
Tijdsspanne: as long as subject was on drug up to approximately 24 hours

Treatment failure is defined as Central venous pressure (CVP) ≥ 20 mm Hg and any one of the following:

  1. Cardiac Index (CI) >/= 1.8 L/min/m2
  2. Administration of >/=0.1 ug/kg/min Epinephrine or Norepinephrine
  3. MAP </= 50 mmHg (or as appropriate for age in pediatrics).
  4. SvO2</= 55% (or < 45% for patients with R to L intracardiac shunting and, thus, cyanosis at baseline.}
as long as subject was on drug up to approximately 24 hours
Change in Mean Pulmonary Artery Pressure (mPAP) From Baseline
Tijdsspanne: 30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours
30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours
Change in Mean Pulmonary Artery Pressure (mPAP) From Baseline
Tijdsspanne: dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour)
dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Cardiac Output (CO) From Baseline
Tijdsspanne: 30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours
30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours
Change in Cardiac Output (CO) From Baseline
Tijdsspanne: dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour)
dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour)
Change in Mean Venous Oxygen Saturation (SvO2) From Baseline
Tijdsspanne: 30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours
SvO2 represents an average of all the venous oxygen saturations of the various organs and tissues.
30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours
Change in Mean Venous Oxygen Saturation (SvO2) From Baseline
Tijdsspanne: dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour)
dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Duke University

Onderzoekers

  • Hoofdonderzoeker: Neil MacIntyre, MD, Duke University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 september 2006

Primaire voltooiing (Werkelijk)

1 januari 2009

Studie voltooiing (Werkelijk)

1 januari 2009

Studieregistratiedata

Eerst ingediend

19 juni 2014

Eerst ingediend dat voldeed aan de QC-criteria

19 juni 2014

Eerst geplaatst (Schatting)

23 juni 2014

Updates van studierecords

Laatste update geplaatst (Schatting)

26 augustus 2014

Laatste update ingediend die voldeed aan QC-criteria

25 augustus 2014

Laatst geverifieerd

1 juni 2014

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • Pro00013737

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