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

Pulmonary Hypertension Clinical Trial

Official 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01310751
• Other study ID #: SJTUMS-200903
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: March 7, 2011
• Last updated: November 22, 2015
• Start date: January 2011
• Est. completion date: December 2013

Study information

• Verified date: November 2015
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 12 Years

Eligibility

Inclusion Criteria:

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

1. Pulse SaO2 smaller than 93% in left-right shunt CHD case (in room air)

2. EKG: right ventricular hypertrophy, right atrial dilatation

3. Chest X-ray: enhanced vascular signs in trans-hilar, loss of blood vessal in bilateral lung fields, pulmonary arterial trunk dilatation, right ventricular enlargement

4. Cardiac echocardiography: fast tricuspid or pulmonary valve regurgitant velocity, ventricular and aortic level bidirectional shunt, or even right-to-left shunt

5. Under-filling of pulmonary capillary, 'pruning' of the peripheral blood vessels

6. Pp/Ps greater than 0.75

7. Qp/Qs smaller than 1.5

8. PVR grater than 9 Wood Unit/m2

9. Rp/Rs graeter than 0.5

Exclusion Criteria:

After corrective procedure for CHD:

1. Deficient anatomy associated with remained intracardiac shunts and severe artrio-ventricular regurgitation

2. Severe arrhythmia led to low cardiac output

3. PLT smaller than 50,000*109/L and obvious bleeding

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Pulmonary Hypertension

Intervention

Drug:
• iloprost nebuliser solusion
50 ng/kg/min inhalation for 10 minutes, q2h for 2 days
• distilled water
2 ml per session

Locations

Country	Name	City	State
China	Cardiac intensive Care Unit,Department of Thoracic and Cardiovascular Sugery,Shanghai Children's Medical Center	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.	The pulmonary heamodynamic variable is measured before, after ilkoprost inhalation instantly and 30-min later.	No
Secondary	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.	No