NCT01320878

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2007

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

October 1, 2007

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

March 22, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 23, 2011

Completed
Last Updated

June 18, 2012

Status Verified

June 1, 2012

Enrollment Period

1.8 years

First QC Date

March 22, 2011

Last Update Submit

June 15, 2012

Conditions

Pulmonary Hypertension

Keywords

pulmonary hypertension

Outcome Measures

Primary Outcomes (1)

  • all cause pulmonary artery pressure

    one year

Secondary Outcomes (5)

  • central venous pressure

    one year

  • blood pressure

    one year

  • cardiac index

    one year

  • pulmonary vascular resistance

    one year

  • mortality

    one year

Study Arms (3)

iloprost low dose group

ACTIVE COMPARATOR

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 high dose group

ACTIVE COMPARATOR

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

Drug: iloprost nebuliser solution

placebo group

PLACEBO COMPARATOR

distilled water 2 ml per session

Drug: distilled water

Interventions

iloprost nebuliser solutionDRUG

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

Also known as: Ventavis
iloprost low dose group
distilled waterDRUG

distilled water 2 ml per session

Also known as: Treeful
placebo group

Eligibility Criteria

Age4 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Shanghai, 200127, China

Location

Related Publications (1)

  • 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.

    PMID: 20424447RESULT

MeSH Terms

Conditions

Hypertension, Pulmonary

Interventions

Iloprost

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • Zhuo-ming Xu, MD,PhD

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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Cardiac intensive Care Unit,Department of Thoracic and Cardiovascular Sugery,Shanghai Children's Medical Center.

Study Record Dates

First Submitted

March 22, 2011

First Posted

March 23, 2011

Study Start

October 1, 2007

Primary Completion

July 1, 2009

Study Completion

December 1, 2009

Last Updated

June 18, 2012

Record last verified: 2012-06

Locations

CN(1)