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Medium-term Venous Access in Congenital Heart Surgery

This study has been completed.
Sponsor:
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00852488
First received: February 4, 2009
Last updated: February 12, 2010
Last verified: February 2010
History of Changes
  Purpose

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.


Condition Intervention
Congenital Heart Surgery
 Procedure: Placement of transthoracic catheter

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Medium-term Venous Access Alternative in Infants Undergoing Congenital Heart Surgery

Resource links provided by NLM:

MedlinePlus related topics: Heart Surgery
U.S. FDA Resources

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: March 2009
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Catheter
Cohort undergoing catheter placement using the new technique being studied
 Procedure: Placement of transthoracic catheter
Placement of transthoracic catheter into the inferior vena cava
Other Names:
  • Bard
  • transthoracic catheter

  Eligibility

Ages Eligible for Study:   up to 365 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00852488

Locations
United States, Tennessee
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: David P Bichell, M.D. Vanderbilt University
  More Information

No publications provided

Responsible Party: David Bichell, M.D., Vanderbilt University
ClinicalTrials.gov Identifier: NCT00852488     History of Changes
Other Study ID Numbers: #080906
Study First Received: February 4, 2009
Last Updated: February 12, 2010
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 21, 2013