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)
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
50 ng/kg/min
Intervention: iloprost nebuliser solusion (Drug)
distilled water
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
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