Clinical trial NCT03282292: Central Venous Catheter Insertion Site and Colonization in Pediatric Cardiac Surgery
Official title: Central Venous Catheter Insertion Site and Catheter Colonization and Bloodstream Infection in Pediatric Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Central Line-associated Bloodstream Infection (CLABSI)
Central Venous Catheter Associated Bloodstream Infection
Heart; Surgery, Heart, Functional Disturbance as Result
Congenital Heart Disease
Newborn; Infection
Lead sponsor: IRCCS Policlinico S. Donato
Sponsor class: OTHER
First posted: 2017-09-13
Enrollment: 0
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: PREVENTION

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

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 or subclavian). In pediatric patients, the femoral site is more commonly used than in adult patients, but there is no sound data on catheter colonization and CLABSI related to the insertion site. The experimental hypothesis of this randomized controlled trial (RCT) is that the jugular insertion site is less likely to induce catheter colonization and CLABSI than the femoral site.

Methods: 160 patients under 1 year and scheduled for cardiac surgery will be included in this RCT; patients will be randomly allocated to the jugular (J Group) or Femoral (F Group). CVC insertion will be performed by one out of three selected expert operators.

The primary endpoint is the catheter colonization based on identification of bacterial grow into the catheter at removal time; CLABSI and CRBSI rate based on the same bacterial identification into the catheter tip and in the blood culture performed in case of signs and symptoms of infection.

Secondary endpoints are mechanical complications defined as arterial puncture immediately identified during procedure, hemothorax and pneumothorax; and procedural difficulty during insertion defined as number of attempts, no guidewire progress, duration of the procedure (time from the completion of the sterile precaution barriers and the catheter fixation.

Eligibility criteria: 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.

Primary outcomes:
measure: CVC colonization
timeFrame: 14 days
measure: CRBSI
timeFrame: 14 days
measure: CLABSI
timeFrame: More than 48 hours
Secondary outcomes:
measure: Mechanical complications
timeFrame: 1 day
measure: Procedural difficulty
timeFrame: 1 hour
Other outcomes:
Locations:
city: San Donato Milanese
country: Italy
facility: IRCCS Policlinico S.Donato
state: Milan
Study officials:
affiliation: IRCCS Policlinico S. Donato
name: Marco Ranucci, MD
role: STUDY_DIRECTOR
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