Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
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

Tracking Information
First Submitted Date  ICMJE September 12, 2017
First Posted Date  ICMJE September 13, 2017
Last Update Posted Date November 7, 2017
Actual Study Start Date  ICMJE September 12, 2017
Estimated Primary Completion Date September 12, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 4, 2017)
  • CVC colonization [ Time Frame: 14 days ]
    CVC positive culture after removal
  • CRBSI [ Time Frame: 14 days ]
    Positive CVC culture and blood stream infection for the same organism
  • CLABSI [ Time Frame: More than 48 hours ]
    A laboratory-confirmed bloodstream infection where central line was in place for more than 48h.
Original Primary Outcome Measures  ICMJE
 (submitted: September 12, 2017)
  • CVC colonization [ Time Frame: 14 days ]
    CVC positive culture after removal
  • CLABSI [ Time Frame: 14 days ]
    Positive CVC culture and blood stream infection for the same organism
Change History Complete list of historical versions of study NCT03282292 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 12, 2017)
  • Mechanical complications [ Time Frame: 1 day ]
    Defined as arterial puncture; hemothorax; pneumothorax
  • Procedural difficulty [ Time Frame: 1 hour ]
    Defined by number of attempts; no guidewire progress
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Central Venous Catheter Insertion Site and Colonization in Pediatric Cardiac Surgery
Official Title  ICMJE Central Venous Catheter Insertion Site and Catheter Colonization and Bloodstream Infection in Pediatric Cardiac Surgery
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomized controlled trial
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Central Line-associated Bloodstream Infection (CLABSI)
  • Central Venous Catheter Associated Bloodstream Infection
  • Heart; Surgery, Heart, Functional Disturbance as Result
  • Congenital Heart Disease
  • Newborn; Infection
Intervention  ICMJE Procedure: Internal jugular vein CVC insertion
Double lumen CVC insertion in the internal jugular vein
Study Arms  ICMJE
  • Experimental: Jugular
    CVC insertion in the left or right internal jugular vein
    Intervention: Procedure: Internal jugular vein CVC insertion
  • Active Comparator: Femoral
    CVC insertion in the right or left femoral vein
    Intervention: Procedure: Internal jugular vein CVC insertion
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 12, 2017)
160
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 12, 2019
Estimated Primary Completion Date September 12, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 1 Year   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Marco Ranucci, MD +390252774754 cardioanestesia@virgilio.it
Contact: Simona Silvetti, MD +390252774754 lu.simo@hotmail.it
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03282292
Other Study ID Numbers  ICMJE PedCVC
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: The dataset will be made available at reasonable request
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Time Frame: November 2017 - November 2020
Responsible Party Marco Ranucci, IRCCS Policlinico S. Donato
Study Sponsor  ICMJE IRCCS Policlinico S. Donato
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Marco Ranucci, MD IRCCS Policlinico San Donato
PRS Account IRCCS Policlinico S. Donato
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP