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Completed

NCT Number: NCT01310751

Study of Inhaled Iloprost in Pediatric Pulmonary Hypertension (PH) After Surgery

The aim of this study is to determine whether inhaled iloprost can be used to prevent and treat PH and PHC while in children after operation of CHD

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Key information

Conditions

Pulmonary Hypertension Cardiovascular Diseases Hypertension Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases Vascular Diseases

Age range

9 day–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

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

Shanghai, 200127, China

About this study

Pulmonary hypertension (PH) is a significant contributor to the postoperative morbidity and mortality of congenital heart disease. Inhaled iloprost has been approved for the treatment of adults with PH, but little is known about the effects in children with PH.

Iloprost is a prostacyclin analogue. When applied by inhalation, it selectively dilates pulmonary vessels without side affecting the systemic circulation. There is no RCTs of iloprost have previously been performed in this indication.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

  • Pulse SaO2 smaller than 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 vessal 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
  • Under-filling of pulmonary capillary, 'pruning' of the peripheral blood vessels
  • Pp/Ps greater than 0.75
  • Qp/Qs smaller than 1.5
  • PVR grater than 9 Wood Unit/m2
  • Rp/Rs graeter than 0.5

Exclusion criteria

After corrective procedure for CHD:

  • Deficient anatomy associated with remained intracardiac shunts and severe artrio-ventricular regurgitation
  • Severe arrhythmia led to low cardiac output
  • PLT smaller than 50,000*109/L and obvious bleeding

Treatment and study plan

iloprost nebuliser solusion

Drug

50 ng/kg/min inhalation for 10 minutes, q2h for 2 days

Other names: Venatvis

distilled water

Drug

2 ml per session

Other names: placebo

Primary outcomes

  1. The primary end point is a composite variable (incidence rate of any events) consisting of reactive PH, PHC and death requiring additional pharmacological or other support administered within the first 48 hours after receiving study drug.

    Time frame: The pulmonary heamodynamic variable is measured before, after ilkoprost inhalation instantly and 30-min later.

    Reactive PH is defined as Pp/Ps greater than 0.5 for more than 30min.

    End point of observation: in case of Pp/Ps greater than 0.5 for more than 30min or Pp/Ps greater than 1 for any time period, drug inhalation will be immediately stopped and other therapies such as NO inhalation and/or iloprost 80 ng/kg/min inhalation will be resorted to treat pulmonary hypertension.

Secondary outcomes

  1. Change from base line of pulmonary heamodynamic measurements: Pp/Ps, PVRI, SVRI

    Time frame: The heamodynamic variable is measured before, after iloprost inhalation instantly and 30-min later.

Sponsors and collaborators

Lead sponsor

Shanghai Jiao Tong University School of Medicine

Other

Registry information

Official study title

Randomized Double-blind Study of Inhaled Iloprost for the Treatment of Pulmonary Hypertension (PH) and Pulmonary Hypertensive Crisis (PHC) After Repair of Congenital Heart Disease (CHD)

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Mar 8, 2011
Registry last updated
Nov 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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