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Study of Inhaled Iloprost for the Treatment of Pulmonary Hypertension After Repair of Congenital Heart Disease

Primary Purpose

Pulmonary Hypertension

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
iloprost nebuliser solution
iloprost nebuliser solution
distilled water
Sponsored by
Shanghai Jiao Tong University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Hypertension focused on measuring pulmonary hypertension

Eligibility Criteria

4 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Before corrective procedure for CHD, two of bellow ten criteria should be met:

  • Decreased respiratory infection & decreased exercise tolerance
  • Pulse SaO2 < 93% in left-right shunt CHD case (in room air)
  • EKG: right ventricular hypertrophy, right atrial dilatation
  • Chest X-ray: enhanced vascular signs in trans-hilar, loss of blood vessel in bilateral lung fields, pulmonary arterial trunk dilatation, right ventricular enlargement
  • Cardiac echocardiography: fast tricuspid or pulmonary valve regurgitant velocity, ventricular and aortic level bidirectional shunt, or even right-to-left shunt
  • Underfilling of pulmonary capillary, 'pruning' of the peripheral blood vessels
  • Pp/Ps > 0.75
  • Qp/Qs <1.5
  • PVR > 9WU/m2
  • Rp/Rs > 0.5

Exclusion Criteria:

  • a body weight of < 2 kg,
  • prematurity (birth 36 weeks postconceptual age)
  • renal dysfunction (creatinine >= 1.5 mg/dL 48 hours before surgery)
  • PLT < 50,000*109/L and obvious bleeding
  • LCOS or hypotension on arrival to the intensive care unit

After corrective procedure for CHD:

  • deficient anatomy associated with remained intracardiac shunts and severe artrio-ventricular regurgitation
  • severe arrhythmia led to low cardiac output

Sites / Locations

  • Cardiac intensive Care Unit,Department of Thoracic and Cardiovascular Sugery,Shanghai Children's Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

iloprost low dose group

iloprost high dose group

placebo group

Arm Description

iloprost 30 ng/kg/min inhalation for 10 minutes,q4h in day time and q6h at night for 2 days

iloprost 50 ng/kg/min inhalation for 10 minutes, q4h in day time and q6h at night for 2 days

distilled water 2 ml per session

Outcomes

Primary Outcome Measures

all cause pulmonary artery pressure

Secondary Outcome Measures

central venous pressure
blood pressure
cardiac index
pulmonary vascular resistance
mortality

Full Information

First Posted
March 22, 2011
Last Updated
June 15, 2012
Sponsor
Shanghai Jiao Tong University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT01320878
Brief Title
Study of Inhaled Iloprost for the Treatment of Pulmonary Hypertension After Repair of Congenital Heart Disease
Official Title
A Randomized Controlled Study of Inhaled Iloprost for the Treatment of Pulmonary Hypertension After Repair of Congenital Heart Disease
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Jiao Tong University School of Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The objective of this study was to assess the efficacy and appropriate dose of iloprost for inhalation in the treatment of postoperative pulmonary hypertension in children with congenital heart defects.
Detailed Description
Pulmonary hypertension is a serious postoperative complication in children with congenital heart defects, which has a high incidence and mortality. Iloprost is a prostacyclin analogue. When applied by inhalation, it selectively dilates pulmonary vessels, without side affecting the systemic circulation. No randomized controlled trials (RCT) of iloprost have previously been performed in this indication. The investigators study is the first RCT of iloprost for inhalation after surgery of children's congenital heart diseases to be performed in this field.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Hypertension
Keywords
pulmonary hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
iloprost low dose group
Arm Type
Active Comparator
Arm Description
iloprost 30 ng/kg/min inhalation for 10 minutes,q4h in day time and q6h at night for 2 days
Arm Title
iloprost high dose group
Arm Type
Active Comparator
Arm Description
iloprost 50 ng/kg/min inhalation for 10 minutes, q4h in day time and q6h at night for 2 days
Arm Title
placebo group
Arm Type
Placebo Comparator
Arm Description
distilled water 2 ml per session
Intervention Type
Drug
Intervention Name(s)
iloprost nebuliser solution
Other Intervention Name(s)
Ventavis
Intervention Description
iloprost 30 ng/kg/min inhalation for 10 minutes,q4h in day time and q6h at night for 2 days
Intervention Type
Drug
Intervention Name(s)
iloprost nebuliser solution
Other Intervention Name(s)
Ventavis
Intervention Description
iloprost 50 ng/kg/min inhalation for 10 minutes, q4h in day time and q6h at night for 2 days
Intervention Type
Drug
Intervention Name(s)
distilled water
Other Intervention Name(s)
Treeful
Intervention Description
distilled water 2 ml per session
Primary Outcome Measure Information:
Title
all cause pulmonary artery pressure
Time Frame
one year
Secondary Outcome Measure Information:
Title
central venous pressure
Time Frame
one year
Title
blood pressure
Time Frame
one year
Title
cardiac index
Time Frame
one year
Title
pulmonary vascular resistance
Time Frame
one year
Title
mortality
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Before corrective procedure for CHD, two of bellow ten criteria should be met: Decreased respiratory infection & decreased exercise tolerance Pulse SaO2 < 93% in left-right shunt CHD case (in room air) EKG: right ventricular hypertrophy, right atrial dilatation Chest X-ray: enhanced vascular signs in trans-hilar, loss of blood vessel in bilateral lung fields, pulmonary arterial trunk dilatation, right ventricular enlargement Cardiac echocardiography: fast tricuspid or pulmonary valve regurgitant velocity, ventricular and aortic level bidirectional shunt, or even right-to-left shunt Underfilling of pulmonary capillary, 'pruning' of the peripheral blood vessels Pp/Ps > 0.75 Qp/Qs <1.5 PVR > 9WU/m2 Rp/Rs > 0.5 Exclusion Criteria: a body weight of < 2 kg, prematurity (birth 36 weeks postconceptual age) renal dysfunction (creatinine >= 1.5 mg/dL 48 hours before surgery) PLT < 50,000*109/L and obvious bleeding LCOS or hypotension on arrival to the intensive care unit After corrective procedure for CHD: deficient anatomy associated with remained intracardiac shunts and severe artrio-ventricular regurgitation severe arrhythmia led to low cardiac output
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhuo-ming Xu, MD,PhD
Organizational Affiliation
Cardiac intensive Care Unit,Department of Thoracic and Cardiovascular Sugery,Shanghai Children's Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Cardiac intensive Care Unit,Department of Thoracic and Cardiovascular Sugery,Shanghai Children's Medical Center
City
Shanghai
ZIP/Postal Code
200127
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
20424447
Citation
Gorenflo M, Gu H, Xu Z. Peri-operative pulmonary hypertension in paediatric patients: current strategies in children with congenital heart disease. Cardiology. 2010;116(1):10-7. doi: 10.1159/000313864. Epub 2010 Apr 24.
Results Reference
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Study of Inhaled Iloprost for the Treatment of Pulmonary Hypertension After Repair of Congenital Heart Disease

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