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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Shanghai Jiao Tong University School of Medicine
Sponsor:
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
  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

  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
Iloprost
Cardiovascular Agents
Hematologic Agents
Pharmacologic Actions
Platelet Aggregation Inhibitors
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on November 24, 2014