Study of Inhaled Iloprost in Pediatric Pulmonary Hypertension (PH) After Surgery
This study is currently recruiting participants.
Verified December 2012 by Shanghai Jiao Tong University School of Medicine
Sponsor:
Shanghai Jiao Tong University School of Medicine
Information provided by (Responsible Party):
Xu Zhuoming, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier:
NCT01310751
First received: March 7, 2011
Last updated: December 24, 2012
Last verified: December 2012
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Pulmonary Hypertension |
Drug: iloprost nebuliser solusion Drug: distilled water |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| 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) |
Resource links provided by NLM:
Further study details as provided by Shanghai Jiao Tong University School of Medicine:
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. [ Time Frame: The pulmonary heamodynamic variable is measured before, after ilkoprost inhalation instantly and 30-min later. ] [ Designated as safety issue: No ]
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 [ Time Frame: The heamodynamic variable is measured before, after iloprost inhalation instantly and 30-min later. ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 160 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | June 2014 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 Name: Venatvis
|
|
Placebo Comparator: distilled water
2ml
|
Drug: distilled water
2 ml per session
Other Name: placebo
|
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.
Eligibility| Ages Eligible for Study: | up to 12 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01310751
Contacts
| Contact: Zhuo-ming Xu, M.D.,PhD | 8621-38626161 ext E6653 | zmxyfb@yahoo.com.cn |
| Contact: Xiao-man Tsai, M.D. | 8621-58393915 | mailofxiaoman@163.com |
Locations
| China | |
| Cardiac intensive Care Unit,Department of Thoracic and Cardiovascular Sugery,Shanghai Children's Medical Center | Recruiting |
| Shanghai, China, 200127 | |
| Contact: Zhuo;ming Xu, M.D., PhD 8621-38626161 ext 6653 zmxyfb@yahoo.com.cn | |
| Contact: Xiao-man Tsai, M.D. 8621-58393915 mailofxiaoman@163.com | |
Sponsors and Collaborators
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 |
More Information
No publications provided
| Responsible Party: | 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 |
| ClinicalTrials.gov Identifier: | NCT01310751 History of Changes |
| Other Study ID Numbers: | SJTUMS-200903 |
| Study First Received: | March 7, 2011 |
| Last Updated: | December 24, 2012 |
| Health Authority: | China: Food and Drug Administration |
Additional relevant MeSH terms:
|
Hypertension Hypertension, Pulmonary Vascular Diseases Cardiovascular Diseases Lung Diseases Respiratory Tract Diseases Iloprost |
Platelet Aggregation Inhibitors Hematologic Agents Therapeutic Uses Pharmacologic Actions Vasodilator Agents Cardiovascular Agents |
ClinicalTrials.gov processed this record on May 19, 2013