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Central Venous Catheter Insertion Site and Colonization in Pediatric Cardiac Surgery (PRECiSE)

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ClinicalTrials.gov Identifier: NCT03282292
Recruitment Status : Recruiting
First Posted : September 13, 2017
Last Update Posted : November 7, 2017
Sponsor:
Information provided by (Responsible Party):
Marco Ranucci, 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.

Condition or disease Intervention/treatment Phase
Central Line-associated Bloodstream Infection (CLABSI) Central Venous Catheter Associated Bloodstream Infection Heart; Surgery, Heart, Functional Disturbance as Result Congenital Heart Disease Newborn; Infection Procedure: Internal jugular vein CVC insertion Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled trial
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Central Venous Catheter Insertion Site and Catheter Colonization and Bloodstream Infection in Pediatric Cardiac Surgery
Actual Study Start Date : September 12, 2017
Estimated Primary Completion Date : September 12, 2019
Estimated Study Completion Date : October 12, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Arm Intervention/treatment
Experimental: Jugular
CVC insertion in the left or right internal jugular vein
Procedure: Internal jugular vein CVC insertion
Double lumen CVC insertion in the internal jugular vein

Active Comparator: Femoral
CVC insertion in the right or left femoral vein
Procedure: Internal jugular vein CVC insertion
Double lumen CVC insertion in the internal jugular vein




Primary Outcome Measures :
  1. CVC colonization [ Time Frame: 14 days ]
    CVC positive culture after removal

  2. CRBSI [ Time Frame: 14 days ]
    Positive CVC culture and blood stream infection for the same organism

  3. CLABSI [ Time Frame: More than 48 hours ]
    A laboratory-confirmed bloodstream infection where central line was in place for more than 48h.


Secondary Outcome Measures :
  1. Mechanical complications [ Time Frame: 1 day ]
    Defined as arterial puncture; hemothorax; pneumothorax

  2. Procedural difficulty [ Time Frame: 1 hour ]
    Defined by number of attempts; no guidewire progress



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 1 Year   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03282292


Contacts
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Contact: Marco Ranucci, MD +390252774754 cardioanestesia@virgilio.it
Contact: Simona Silvetti, MD +390252774754 lu.simo@hotmail.it

Locations
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Italy
IRCCS Policlinico S.Donato Recruiting
San Donato Milanese, Milan, Italy, 20097
Contact: Marco Ranucci, MD    00390252774 ext 754    cardioanestesia@virgilio.it   
Principal Investigator: Marco Ranucci, MD         
Principal Investigator: Simona Silvetti, MD         
Sub-Investigator: Tommaso Aloisio, MD         
Sub-Investigator: Anna Cazzaniga, MD         
Sponsors and Collaborators
IRCCS Policlinico S. Donato
Investigators
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Study Director: Marco Ranucci, MD IRCCS Policlinico San Donato

Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Marco Ranucci, Director Clinical Research, IRCCS Policlinico S. Donato
ClinicalTrials.gov Identifier: NCT03282292     History of Changes
Other Study ID Numbers: PedCVC
First Posted: September 13, 2017    Key Record Dates
Last Update Posted: November 7, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The dataset will be made available at reasonable request
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: November 2017 - November 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Infection
Communicable Diseases
Heart Diseases
Pathologic Processes
Cardiovascular Diseases