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OpenTrials
Completed

NCT Number: NCT00852488

Medium-term Venous Access in Congenital Heart Surgery

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.

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Key information

Conditions

Congenital Heart Surgery

Age range

1 day–365 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Monroe Carell Jr. Children's Hospital at Vanderbilt

Nashville, Tennessee, 37232, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placement of transthoracic catheter

Procedure

Placement of transthoracic catheter into the inferior vena cava

Other names: Bard, transthoracic catheter

Primary outcomes

  1. Days of complication-free use. Morbidity (infection, malposition, bleeding, thrombosis, need for removal for catheter-related complication). Need for additional catheter placement or reintervention.

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Feb 27, 2009
Registry last updated
May 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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