Study of Inhaled Iloprost in Pediatric Pulmonary Hypertension (PH) After Surgery
|Pulmonary Hypertension||Drug: iloprost nebuliser solusion Drug: distilled water||Phase 2 Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, 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)|
- 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.
- 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. ]
|Study Start Date:||January 2011|
|Study Completion Date:||December 2013|
|Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Experimental: iloprost nebuliser solusion
Drug: iloprost nebuliser solusion
50 ng/kg/min inhalation for 10 minutes, q2h for 2 days
Other Name: Venatvis
Placebo Comparator: distilled water
Drug: distilled water
2 ml per session
Other Name: placebo
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01310751
|Cardiac intensive Care Unit,Department of Thoracic and Cardiovascular Sugery,Shanghai Children's Medical Center|
|Shanghai, China, 200127|
|Study Director:||Xu Zhuo-ming, M.D., PhD.||Cardiac intensive Care Unit,Department of Thoracic and Cardiovascular Sugery,Shanghai Children's Medical Center|