Medium-term Venous Access in Congenital Heart Surgery

Congenital Heart Surgery Clinical Trial

Official title:

A Medium-term Venous Access Alternative in Infants Undergoing Congenital Heart Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00852488
• Other study ID #: #080906
• Status: Completed
• Phase: N/A
• First received: February 4, 2009
• Last updated: April 27, 2017
• Start date: March 2009
• Est. completion date: January 2010

Study information

• Verified date: February 2010
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is designed to evaluate medium-term central venous catheter placement in infants undergoing complex cardiac surgery using a new technique. This technique involves placement of the catheter into the inferior vena cava through a subcutaneous tunnel and through a tunnel between pericardium and diaphragm.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 365 Days

Eligibility

Inclusion Criteria:

• Infants undergoing surgical correction or palliation of congenital heart disease via sternotomy

• Age 0-365 days

• Anticipated intensive care stay over 10 days

• Need for central venous access or prolonged venous access

Exclusion Criteria:

• Presence of access that is likely to last more than 10 days at time of operation

• Septic shock

• Known inferior vena cava thrombosis

• Operations not approached by sternotomy

Related Conditions & MeSH terms

• Congenital Heart Surgery

Intervention

Procedure:
• Placement of transthoracic catheter
Placement of transthoracic catheter into the inferior vena cava

Locations

Country	Name	City	State
United States	Monroe Carell Jr. Children's Hospital at Vanderbilt	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Days of complication-free use. Morbidity (infection, malposition, bleeding, thrombosis, need for removal for catheter-related complication). Need for additional catheter placement or reintervention.		Until catheter no longer needed; it is not anticipated that these remain longer than 2 weeks. Prior to discharge all will have been removed and final assessment of primary outcome will be obtained