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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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 November 20, 2014