MedTrace Logo

Study of Remodulin® in Pediatric Pulmonary Hypertension With Single Ventricular Physiology After Fontan Surgery

NCT02865733 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2020-10-28

No results posted yet for this study

Summary

The aim of this study is to determine the safety and efficiency of Remodulin®（Treprostinil Injection）to reduce the pulmonary arterial pressure and prevent pulmonary hypertension (PH) after Fontan operation with univentricular physiology.

Conditions

  • Pulmonary Hypertension

Interventions

DRUG

Remodulin

After Fontan operation, the mean pulmonary arterial pressure (mPAP)evaluated by CVP or transpulmonary pressure gradient(TPG) evaluated by Echo will be measured firstly, if the data met the criteria, and the patients were enrolled in the experimental group, the patients would be administrated intravenously of Remodulin® with the beginning of 5ng/kg/min, with the rate of 10ng/kg/min every 30 minutes up to 80ng/kg/min.

DRUG

distilled water

After Fontan operation, the mPAP (evaluated by CVP) or TPG (evaluated by Echo) will be measured firstly, if the data met the criteria, and the patients were enrolled in placebo group, then the patients would be administrated intravenously of distilled water with the beginning of 0.15ml/hr, with the rate of 0.3ml/hr every 30 minutes up to 2.45ml/hr.

Sponsors & Collaborators

  • Shanghai Jiao Tong University School of Medicine

    lead OTHER

Principal Investigators

  • Zhuoming Xu, M.D.,Ph,D. · Cardiac intensive Care Unit,Department of Thoracic and Cardiovascular Surgery

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-01
Primary Completion
2018-12-31
Completion
2019-08-20

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02865733 on ClinicalTrials.gov