search
Back to results

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

Primary Purpose

Pulmonary Hypertension

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
iloprost nebuliser solusion
distilled water
Sponsored by
Shanghai Jiao Tong University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pulmonary Hypertension

Eligibility Criteria

9 Days - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

iloprost nebuliser solusion

distilled water

Arm Description

50 ng/kg/min

2ml

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
March 7, 2011
Last Updated
November 22, 2015
Sponsor
Shanghai Jiao Tong University School of Medicine
search

1. Study Identification

Unique Protocol Identification Number
NCT01310751
Brief Title
Study of Inhaled Iloprost in Pediatric Pulmonary Hypertension (PH) After Surgery
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)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Jiao Tong University School of Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Hypertension

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
iloprost nebuliser solusion
Arm Type
Experimental
Arm Description
50 ng/kg/min
Arm Title
distilled water
Arm Type
Placebo Comparator
Arm Description
2ml
Intervention Type
Drug
Intervention Name(s)
iloprost nebuliser solusion
Other Intervention Name(s)
Venatvis
Intervention Description
50 ng/kg/min inhalation for 10 minutes, q2h for 2 days
Intervention Type
Drug
Intervention Name(s)
distilled water
Other Intervention Name(s)
placebo
Intervention Description
2 ml per session
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
The pulmonary heamodynamic variable is measured before, after ilkoprost inhalation instantly and 30-min later.
Secondary Outcome Measure Information:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Days
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xu Zhuo-ming, M.D., PhD.
Organizational Affiliation
Cardiac intensive Care Unit,Department of Thoracic and Cardiovascular Sugery,Shanghai Children's Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Cardiac intensive Care Unit,Department of Thoracic and Cardiovascular Sugery,Shanghai Children's Medical Center
City
Shanghai
ZIP/Postal Code
200127
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs