Central Venous Catheter Insertion Site and Colonization in Pediatric Cardiac Surgery

Not Applicable

Withdrawn

• Conditions: Central Venous Catheter Associated Bloodstream Infection; Heart; Surgery, Heart, Functional Disturbance as Result; Central Line-associated Bloodstream Infection (CLABSI); Newborn; Infection; Congenital Heart Disease
• Interventions: Procedure: Internal jugular vein CVC insertion

• Registration Number: NCT03282292
• Lead Sponsor: IRCCS Policlinico S. Donato

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.

Study Timeline

• Study Start: 2017-09-12
• Study First Submitted: 2017-09-12
• Study First Submitted QC: 2017-09-12
• Study First Posted: 2017-09-13
• Primary Completion: 2019-09-12
• Study Completion: 2019-10-12
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-16
• Last Update Posted: 2023-11-18

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Jugular	Internal jugular vein CVC insertion	CVC insertion in the left or right internal jugular vein
Femoral	Internal jugular vein CVC insertion	CVC insertion in the right or left femoral vein

Primary Outcome Measures

Name	Time	Method
CVC colonization	14 days	CVC positive culture after removal
CRBSI	14 days	Positive CVC culture and blood stream infection for the same organism
CLABSI	More than 48 hours	A laboratory-confirmed bloodstream infection where central line was in place for more than 48h.

Secondary Outcome Measures

Name	Time	Method
Procedural difficulty	1 hour	Defined by number of attempts; no guidewire progress
Mechanical complications	1 day	Defined as arterial puncture; hemothorax; pneumothorax

Trial Locations

Locations (1)

IRCCS Policlinico S.Donato; 🇮🇹 San Donato Milanese, Milan, Italy