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Perioperative Treprostinil in Pediatric Patients Undergoing the Fontan Operation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02498444
Recruitment Status : Active, not recruiting
First Posted : July 15, 2015
Last Update Posted : March 6, 2020
Information provided by (Responsible Party):
Jeffrey A. Feinstein, Stanford University

Brief Summary:

The purpose of this study is to test the efficacy of treprostinil in the perioperative non-fenestrated, extracardiac Fontan patients in order to reduce duration of chest tube drainage (in days).

The Fontan operation is performed for patients with single ventricle physiology as the final palliation to create a series circulation, with passive systemic venous return to the pulmonary arteries and the single ventricle solely providing systemic output.

Patients undergoing extracardiac Fontan tend to have elevation of Fontan pressures immediately following the operation with inflammation from surgery requiring additional fluid administration to maintain blood pressure. Increased Fontan pressures and fluid overload lead to prolonged chest tube drainage.

The hypothesis is that treprostinil, a prostacyclin drug that dilates the pulmonary arteries, will improve immediate postoperative Fontan pressures. Treprostinil is not FDA approved for this use. Anecdotally and in a small case series, prostacyclin therapy has been shown to assist in transitioning patients off nitric oxide. The investigators believe that this improvement in hemodynamics will decrease duration of chest tube drainage resulting in a shorter length of hospital stay.

Condition or disease Intervention/treatment Phase
Single Ventricle Drug: Treprostinil Not Applicable

Detailed Description:

In order to understand the effect of treprostinil on Fontan patients, this study has two parts:

  1. reactivity testing with inhaled treprostinil in the cardiac catheterization lab for pre-Fontan patients undergoing routine catheterization in anticipation of the Fontan operation;
  2. perioperative use of subcutaneous treprostinil starting immediately pre-op until postoperative day #7 to improve immediate postoperative hemodynamics and ultimately reduce overall length of hospital stay.

The investigators hope to learn how pulmonary vasodilator therapy affects and/or improves post- operative hemodynamics following the Fontan operation. This knowledge would be very important in the care of single ventricle patients following the Fontan operation if there is improvement of immediate outcomes and reduction of hospital length of stay. On a broader scale, if the use of treprostinil in perioperative Fontan patients can achieve the same results other centers achieve with the use of a fenestration this may have wide scale implications in the nationwide treatment of Fontan patients.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Perioperative Treprostinil in Pediatric Patients Undergoing the Fontan Operation
Study Start Date : September 2015
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Treprostinil
The subcutaneous continuous treprostinil infusion will start at a dose of 2 ng/kg/min. The dose will be increased over the first 24 hours to goal 10 ng/kg/min through day five. On postoperative day six, the dose will be decreased by 2 ng/kg/min every 8 hours with plans for discontinuation on postoperative day seven.
Drug: Treprostinil
Administration of drug (treprostinil) vs placebo (saline) in the post-operative period
Other Name: Remodulin

Placebo Comparator: Saline
Saline administration via subcutaneous infusion
Drug: Treprostinil
Administration of drug (treprostinil) vs placebo (saline) in the post-operative period
Other Name: Remodulin

Primary Outcome Measures :
  1. Chest tube duration [ Time Frame: 2-3 wks ]

Secondary Outcome Measures :
  1. Length of hospital stay [ Time Frame: 2-3 wks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Pediatric patient undergoing Fontan operation and/or pre-Fontan cardiac catheterization at Lucile Packard Children's Hospital (LPCH)

Exclusion Criteria:

  • Platelet count < 50K (treprostinil can act as a platelet inhibitor and this may place patient at additional risk of bleeding if already thrombocytopenic)
  • Dermatologic condition that renders the patient unable to tolerate a subcutaneous infusion (can still take part in inhaled vasodilator testing during cardiac catheterization)
  • Currently receiving any vasodilator therapy specifically for the purpose of pulmonary vsasodilation (phosphodiesterase type 5 inhibitor, endothelia receptor antagonist and/or prostacyclin).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02498444

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United States, California
Lucile Packard Children's Hospital, Stanford
Palo Alto, California, United States, 94304
Sponsors and Collaborators
Stanford University
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Principal Investigator: Jeffrey Feinstein Stanford University
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Responsible Party: Jeffrey A. Feinstein, Principle Investigator, Stanford University Identifier: NCT02498444    
Other Study ID Numbers: 33852
First Posted: July 15, 2015    Key Record Dates
Last Update Posted: March 6, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Jeffrey A. Feinstein, Stanford University:
Single ventricle
Additional relevant MeSH terms:
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Antihypertensive Agents