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Clinical Trials/NCT01310751
NCT01310751CompletedPhase 2

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)

Shanghai Jiao Tong University School of Medicine1 site in 1 country36 target enrollmentStarted: January 2011Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Completed
Sponsor
Enrollment
36
Locations
1
Primary Endpoint
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.

Study Overview

Brief Summary

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

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
9 Days to 12 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

iloprost nebuliser solusion

Experimental

50 ng/kg/min

Intervention: iloprost nebuliser solusion (Drug)

distilled water

Placebo Comparator

2ml

Intervention: distilled water (Drug)

Outcomes

Primary Outcomes

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

  • Change from base line of pulmonary heamodynamic measurements: Pp/Ps, PVRI, SVRI(The heamodynamic variable is measured before, after iloprost inhalation instantly and 30-min later.)

Investigators

Sponsor
Shanghai Jiao Tong University School of Medicine
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Xu Zhuoming

chief cadiologist,Director of ICU, Cardiac intensive Care Unit,Department of Thoracic and Cardiovascular Sugery,Shanghai Children's Medical Center.

Shanghai Jiao Tong University School of Medicine

Study Sites (1)

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