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Inhaled Aerosolized Prostacyclin for Pulmonary Hypertension Requiring Inhaled Nitric Oxide

2014년 8월 25일 업데이트: 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.

연구 개요

상태

종료됨

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (실제)

27

단계

  • 4단계

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 어린이
  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위화되지 않음
  • 중재 모델: 크로스오버 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
의약품: Inhaled Iloprost
A 20 mcg dose of Iloprost will be given initially.
다른 이름들:
  • 벤타비스
실험적: 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.
의약품: Inhaled Iloprost
A 20 mcg dose of Iloprost will be given initially.
다른 이름들:
  • 벤타비스

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Percent Change in Oxygen Saturation (SpO2) From Baseline
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)

2차 결과 측정

결과 측정
측정값 설명
기간
Change in Cardiac Output (CO) From Baseline
기간: 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
기간: 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
기간: 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
기간: 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)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Duke University

수사관

  • 수석 연구원: Neil MacIntyre, MD, Duke University

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2006년 9월 1일

기본 완료 (실제)

2009년 1월 1일

연구 완료 (실제)

2009년 1월 1일

연구 등록 날짜

최초 제출

2014년 6월 19일

QC 기준을 충족하는 최초 제출

2014년 6월 19일

처음 게시됨 (추정)

2014년 6월 23일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2014년 8월 26일

QC 기준을 충족하는 마지막 업데이트 제출

2014년 8월 25일

마지막으로 확인됨

2014년 6월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • Pro00013737

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

폐 고혈압에 대한 임상 시험

Inhaled Iloprost에 대한 임상 시험

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위치

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