Perioperative Treprostinil in Pediatric Patients Undergoing the Fontan Operation

NCT02498444 | Terminated Results DMC

• 1 other identifier: 33852
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Single Ventricle

Keywords

Fontan; Treprostinil; Remodulin; Single ventricle

Outcome Measures

Primary Outcomes (1)

• Chest Tube Duration

  This outcome measures the number of days that chest tubes were in place postoperatively.

  2-3 wks

Secondary Outcomes (4)

• Length of Hospital Stay

  2-3 wks

• Postoperative Fontan Pressure

  postoperative hour 0, 12 and 24

• Postoperative Atrial Pressure

  postoperative hour 0, 12 and 24

• Postoperative Transpulmonary Gradient

  postoperative hour 0, 12 and 24

Study Arms (2)

Treprostinil

EXPERIMENTAL

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

Saline

PLACEBO COMPARATOR

Saline administration via subcutaneous infusion

Drug: Treprostinil

Interventions

Treprostinil DRUG

Administration of drug (treprostinil) vs placebo (saline) in the post-operative period

Also known as: Remodulin

Saline; Treprostinil

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Lucile Packard Children's Hospital, Stanford

Palo Alto, California, 94304, United States

Location

Related 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:S1053-2498(17)31993-9. doi: 10.1016/j.healun.2017.09.008. Online ahead of print. No abstract available.

  PMID: 29126699 BACKGROUND

MeSH Terms

Conditions

Univentricular Heart

Interventions

treprostinil

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Limitations and Caveats

Early termination based on futility analysis performed prior to full study enrollment led to smaller number of subjects analyzed than initially outlined by power analysis.

Results Point of Contact

• Title: Jeffrey Feinstein, MD
• Organization: Stanford University

jeff.feinstein@stanford.edu

6507252297

Study Officials

• Jeffrey Feinstein

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: July 13, 2015
• First Posted: July 15, 2015
• Study Start: September 1, 2015
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: March 31, 2022
• Results First Posted: March 31, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)