Status:

WITHDRAWN

Central Venous Catheter Insertion Site and Colonization in Pediatric Cardiac Surgery

Lead Sponsor:

IRCCS Policlinico S. Donato

Conditions:

Central Line-associated Bloodstream Infection (CLABSI)

Central Venous Catheter Associated Bloodstream Infection

Eligibility:

All Genders

Up to 1 years

Phase:

NA

Brief Summary

Randomized controlled trial comparing femoral vs internal jugular insertion site of central venous catheters (CVC) in newborns and infants undergoing cardiac surgery. The experimental hypothesis is th...

Detailed Description

Background: in adult patients, the femoral site of insertion of CVC is notoriously at higher risk of colonization and central-line associated bloodstream infection (CLABSI) than other sites (jugular o...

Eligibility Criteria

Inclusion

  • Planned cardiac surgery Age \<1 year Eligibility for both insertion sites (jugular and femoral) for CVC Availability of at least one out of the three chosen expert operators

Exclusion

  • Emergency surgery Known vascular anatomic anomalies Previous cardiac surgery in the last 6 months No expert operator availability Intensive Care unit before surgery Central venous catheter inside at the time of randomization
  • Withdraw criteria (only for the first endpoint):
  • Impossibility to placement catheter in the selected site.

Key Trial Info

Start Date :

September 12 2017

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

October 12 2019

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT03282292

Start Date

September 12 2017

End Date

October 12 2019

Last Update

November 18 2023

Active Locations (1)

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1

IRCCS Policlinico S.Donato

San Donato Milanese, Milan, Italy, 20097