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

NCT01310751 | Completed Phase 2 DMC

• 1 other identifier: SJTUMS-200903
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Conditions

Pulmonary Hypertension

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

Study Arms (2)

iloprost nebuliser solusion

EXPERIMENTAL

50 ng/kg/min

Drug: iloprost nebuliser solusion

distilled water

PLACEBO COMPARATOR

2ml

Drug: distilled water

Interventions

iloprost nebuliser solusion DRUG

50 ng/kg/min inhalation for 10 minutes, q2h for 2 days

Also known as: Venatvis

iloprost nebuliser solusion

distilled water DRUG

2 ml per session

Also known as: placebo

distilled water

Eligibility Criteria

• Age: 9 Days - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

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

Shanghai, 200127, China

Location

MeSH Terms

Conditions

Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Xu Zhuo-ming, M.D., PhD.

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief cadiologist,Director of ICU, Cardiac intensive Care Unit,Department of Thoracic and Cardiovascular Sugery,Shanghai Children's Medical Center.

Study Record Dates

• First Submitted: March 7, 2011
• First Posted: March 8, 2011
• Study Start: January 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: November 24, 2015

Record last verified: 2015-11

Locations

CN (1)