NCT00852488

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 4, 2009

Completed
23 days until next milestone

First Posted

Study publicly available on registry

February 27, 2009

Completed
2 days until next milestone

Study Start

First participant enrolled

March 1, 2009

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

May 1, 2017

Status Verified

February 1, 2010

Enrollment Period

10 months

First QC Date

February 4, 2009

Last Update Submit

April 27, 2017

Conditions

Congenital Heart Surgery

Outcome Measures

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.

    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

Study Arms (1)

Catheter

EXPERIMENTAL

Cohort undergoing catheter placement using the new technique being studied

Procedure: Placement of transthoracic catheter

Interventions

Placement of transthoracic catheterPROCEDURE

Placement of transthoracic catheter into the inferior vena cava

Also known as: Bard, transthoracic catheter
Catheter

Eligibility Criteria

Age1 Day - 365 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Monroe Carell Jr. Children's Hospital at Vanderbilt

Nashville, Tennessee, 37232, United States

Location

Study Officials

  • David P Bichell, M.D.

    Vanderbilt University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 4, 2009

First Posted

February 27, 2009

Study Start

March 1, 2009

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

May 1, 2017

Record last verified: 2010-02

Locations

US(1)