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Medium-term Venous Access in Congenital Heart Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00852488
First Posted: February 27, 2009
Last Update Posted: May 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
David Bichell, Vanderbilt University Medical Center
  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: Intervention Model: Single Group Assignment
Masking: None (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 David Bichell, Vanderbilt University Medical Center:

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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 365 Days   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00852488


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

Responsible Party: David Bichell, Professor, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT00852488     History of Changes
Other Study ID Numbers: #080906
First Submitted: February 4, 2009
First Posted: February 27, 2009
Last Update Posted: May 1, 2017
Last Verified: February 2010