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

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)

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

Study Overview

• Status: Completed
• Conditions: Pulmonary Hypertension
• Intervention / Treatment: Drug: iloprost nebuliser solusion; Drug: distilled water

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 Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 200127
    • Cardiac intensive Care Unit,Department of Thoracic and Cardiovascular Sugery,Shanghai Children's Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 week to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: iloprost nebuliser solusion; 50 ng/kg/min	Drug: iloprost nebuliser solusion; 50 ng/kg/min inhalation for 10 minutes, q2h for 2 days; Other Names: Venatvis
Placebo Comparator: distilled water; 2ml	Drug: distilled water; 2 ml per session; Other Names: placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Secondary Outcome Measures

Outcome Measure	Time Frame
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.

Collaborators and Investigators

• Sponsor: Shanghai Jiao Tong University School of Medicine
• Investigators: Study Director: Xu Zhuo-ming, M.D., PhD., Cardiac intensive Care Unit,Department of Thoracic and Cardiovascular Sugery,Shanghai Children's Medical Center

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: March 7, 2011
• First Submitted That Met QC Criteria: March 7, 2011
• First Posted (Estimate): March 8, 2011

Study Record Updates

• Last Update Posted (Estimate): November 24, 2015
• Last Update Submitted That Met QC Criteria: November 22, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension; Hypertension, Pulmonary; Vasodilator Agents; Platelet Aggregation Inhibitors; Iloprost
• Other Study ID Numbers: SJTUMS-200903