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

June 15, 2012 updated by: Xu Zhuoming, Shanghai Jiao Tong University School of Medicine

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China, 200127
        • Cardiac intensive Care Unit,Department of Thoracic and Cardiovascular Sugery,Shanghai Children's Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: iloprost low dose group
iloprost 30 ng/kg/min inhalation for 10 minutes,q4h in day time and q6h at night for 2 days
Drug: iloprost nebuliser solution
iloprost 30 ng/kg/min inhalation for 10 minutes,q4h in day time and q6h at night for 2 days
Other Names:
  • Ventavis
Drug: iloprost nebuliser solution
iloprost 50 ng/kg/min inhalation for 10 minutes, q4h in day time and q6h at night for 2 days
Other Names:
  • Ventavis
Active Comparator: iloprost high dose group
iloprost 50 ng/kg/min inhalation for 10 minutes, q4h in day time and q6h at night for 2 days
Drug: iloprost nebuliser solution
iloprost 30 ng/kg/min inhalation for 10 minutes,q4h in day time and q6h at night for 2 days
Other Names:
  • Ventavis
Drug: iloprost nebuliser solution
iloprost 50 ng/kg/min inhalation for 10 minutes, q4h in day time and q6h at night for 2 days
Other Names:
  • Ventavis
Placebo Comparator: placebo group
distilled water 2 ml per session
Drug: distilled water
distilled water 2 ml per session
Other Names:
  • Treeful

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
all cause pulmonary artery pressure
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
mortality
Time Frame: one year
one year
blood pressure
Time Frame: one year
one year
central venous pressure
Time Frame: one year
one year
cardiac index
Time Frame: one year
one year
pulmonary vascular resistance
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Jiao Tong University School of Medicine

Investigators

  • Study Director: Zhuo-ming Xu, MD,PhD, Cardiac intensive Care Unit,Department of Thoracic and Cardiovascular Sugery,Shanghai Children's Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

March 22, 2011

First Submitted That Met QC Criteria

March 22, 2011

First Posted (Estimate)

March 23, 2011

Study Record Updates

Last Update Posted (Estimate)

June 18, 2012

Last Update Submitted That Met QC Criteria

June 15, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SJTUMS-10-16

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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