WithdrawnNot Applicable

Central Venous Catheter Insertion Site and Colonization in Pediatric Cardiac Surgery

Stopped: Co-PI responsible for study procedures moved to another hospital

Italy0Started 2017-09-12

Plain-language 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 that the jugular insertion site is superior to the femoral in terms of catheter colonization.

Who can participate

Age range1 Year

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: 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 Criteria: 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.

What they're measuring

CVC colonization

Timeframe: 14 days

CRBSI

Timeframe: 14 days

CLABSI

Timeframe: More than 48 hours

Trial details

NCT IDNCT03282292

SponsorIRCCS Policlinico S. Donato

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-09-12

View on ClinicalTrials.gov More Central Line-associated Bloodstream Infection (CLABSI) trials