Perioperative Treprostinil in Pediatric Patients Undergoing the Fontan Operation

Single Ventricle Clinical Trial

Official title:

Perioperative Treprostinil in Pediatric Patients Undergoing the Fontan Operation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02498444
• Other study ID #: 33852
• Status: Terminated
• Phase: N/A
• Start date: September 2015
• Est. completion date: December 2020

Study information

• Verified date: March 2022
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to test the efficacy of treprostinil (TRE) 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 34
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 18 Years

Eligibility

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 vasodilation (phosphodiesterase type 5 inhibitor, endothelia receptor antagonist and/or prostacyclin).

Related Conditions & MeSH terms

• Single Ventricle
• Univentricular Heart

Intervention

Drug:
• Treprostinil
Administration of drug (treprostinil) vs placebo (saline) in the post-operative period

Locations

Country	Name	City	State
United States	Lucile Packard Children's Hospital, Stanford	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

References & Publications (1)

Handler SS, Ogawa MT, Hopper RK, Sakarovitch C, Feinstein JA. Subcutaneous treprostinil in pediatric patients with failing single-ventricle physiology. J Heart Lung Transplant. 2017 Sep 14. pii: S1053-2498(17)31993-9. doi: 10.1016/j.healun.2017.09.008. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Chest Tube Duration	This outcome measures the number of days that chest tubes were in place postoperatively.	2-3 wks
Secondary	Length of Hospital Stay	This outcome measures the hospital length of stays in days.	2-3 wks
Secondary	Postoperative Fontan Pressure	Patient hemodynamics as measured by invasive postoperative lines were recorded and compared between groups	postoperative hour 0, 12 and 24
Secondary	Postoperative Atrial Pressure	Patient hemodynamics as measured by invasive postoperative lines were recorded and compared between groups	postoperative hour 0, 12 and 24
Secondary	Postoperative Transpulmonary Gradient	Patient hemodynamics as measured by invasive postoperative lines were recorded and compared between groups. Transpulmonary pressure gradient is defined as the difference between mean pulmonary artery pressure and left atrial pressure (commonly estimated by a pulmonary artery wedge pressure).	postoperative hour 0, 12 and 24