<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03282292</url>
  </required_header>
  <id_info>
    <org_study_id>PedCVC</org_study_id>
    <nct_id>NCT03282292</nct_id>
  </id_info>
  <brief_title>Central Venous Catheter Insertion Site and Colonization in Pediatric Cardiac Surgery</brief_title>
  <acronym>PRECiSE</acronym>
  <official_title>Central Venous Catheter Insertion Site and Catheter Colonization and Bloodstream Infection in Pediatric Cardiac Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>IRCCS Policlinico S. Donato</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>IRCCS Policlinico S. Donato</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Randomized controlled trial comparing femoral vs internal jugular insertion site of central&#xD;
      venous catheters (CVC) in newborns and infants undergoing cardiac surgery. The experimental&#xD;
      hypothesis is that the jugular insertion site is superior to the femoral in terms of catheter&#xD;
      colonization.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: in adult patients, the femoral site of insertion of CVC is notoriously at higher&#xD;
      risk of colonization and central-line associated bloodstream infection (CLABSI) than other&#xD;
      sites (jugular or subclavian). In pediatric patients, the femoral site is more commonly used&#xD;
      than in adult patients, but there is no sound data on catheter colonization and CLABSI&#xD;
      related to the insertion site. The experimental hypothesis of this randomized controlled&#xD;
      trial (RCT) is that the jugular insertion site is less likely to induce catheter colonization&#xD;
      and CLABSI than the femoral site.&#xD;
&#xD;
      Methods: 160 patients under 1 year and scheduled for cardiac surgery will be included in this&#xD;
      RCT; patients will be randomly allocated to the jugular (J Group) or Femoral (F Group). CVC&#xD;
      insertion will be performed by one out of three selected expert operators.&#xD;
&#xD;
      The primary endpoint is the catheter colonization based on identification of bacterial grow&#xD;
      into the catheter at removal time; CLABSI and CRBSI rate based on the same bacterial&#xD;
      identification into the catheter tip and in the blood culture performed in case of signs and&#xD;
      symptoms of infection.&#xD;
&#xD;
      Secondary endpoints are mechanical complications defined as arterial puncture immediately&#xD;
      identified during procedure, hemothorax and pneumothorax; and procedural difficulty during&#xD;
      insertion defined as number of attempts, no guidewire progress, duration of the procedure&#xD;
      (time from the completion of the sterile precaution barriers and the catheter fixation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 12, 2017</start_date>
  <completion_date type="Anticipated">October 12, 2019</completion_date>
  <primary_completion_date type="Anticipated">September 12, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Randomized controlled trial</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>CVC colonization</measure>
    <time_frame>14 days</time_frame>
    <description>CVC positive culture after removal</description>
  </primary_outcome>
  <primary_outcome>
    <measure>CRBSI</measure>
    <time_frame>14 days</time_frame>
    <description>Positive CVC culture and blood stream infection for the same organism</description>
  </primary_outcome>
  <primary_outcome>
    <measure>CLABSI</measure>
    <time_frame>More than 48 hours</time_frame>
    <description>A laboratory-confirmed bloodstream infection where central line was in place for more than 48h.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mechanical complications</measure>
    <time_frame>1 day</time_frame>
    <description>Defined as arterial puncture; hemothorax; pneumothorax</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Procedural difficulty</measure>
    <time_frame>1 hour</time_frame>
    <description>Defined by number of attempts; no guidewire progress</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">160</enrollment>
  <condition>Central Line-associated Bloodstream Infection (CLABSI)</condition>
  <condition>Central Venous Catheter Associated Bloodstream Infection</condition>
  <condition>Heart; Surgery, Heart, Functional Disturbance as Result</condition>
  <condition>Congenital Heart Disease</condition>
  <condition>Newborn; Infection</condition>
  <arm_group>
    <arm_group_label>Jugular</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>CVC insertion in the left or right internal jugular vein</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Femoral</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>CVC insertion in the right or left femoral vein</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Internal jugular vein CVC insertion</intervention_name>
    <description>Double lumen CVC insertion in the internal jugular vein</description>
    <arm_group_label>Femoral</arm_group_label>
    <arm_group_label>Jugular</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Planned cardiac surgery Age &lt;1 year Eligibility for both insertion sites (jugular and&#xD;
        femoral) for CVC Availability of at least one out of the three chosen expert operators&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Emergency surgery Known vascular anatomic anomalies Previous cardiac surgery in the last 6&#xD;
        months No expert operator availability Intensive Care unit before surgery Central venous&#xD;
        catheter inside at the time of randomization&#xD;
&#xD;
        Withdraw criteria (only for the first endpoint):&#xD;
&#xD;
        Impossibility to placement catheter in the selected site.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>1 Year</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marco Ranucci, MD</last_name>
    <role>Study Director</role>
    <affiliation>IRCCS Policlinico S. Donato</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Marco Ranucci, MD</last_name>
    <phone>+390252774754</phone>
    <email>cardioanestesia@virgilio.it</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Simona Silvetti, MD</last_name>
    <phone>+390252774754</phone>
    <email>lu.simo@hotmail.it</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>IRCCS Policlinico S.Donato</name>
      <address>
        <city>San Donato Milanese</city>
        <state>Milan</state>
        <zip>20097</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marco Ranucci, MD</last_name>
      <phone>00390252774</phone>
      <phone_ext>754</phone_ext>
      <email>cardioanestesia@virgilio.it</email>
    </contact>
    <investigator>
      <last_name>Marco Ranucci, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Simona Silvetti, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Tommaso Aloisio, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Anna Cazzaniga, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <results_reference>
    <citation>Collignon P, Soni N, Pearson I, Sorrell T, Woods P. Sepsis associated with central vein catheters in critically ill patients. Intensive Care Med. 1988;14(3):227-31. doi: 10.1007/BF00717995.</citation>
    <PMID>3379183</PMID>
  </results_reference>
  <results_reference>
    <citation>Pearson ML. Guideline for prevention of intravascular device-related infections. Part I. Intravascular device-related infections: an overview. The Hospital Infection Control Practices Advisory Committee. Am J Infect Control. 1996 Aug;24(4):262-77. doi: 10.1016/s0196-6553(96)90058-9. No abstract available.</citation>
    <PMID>8870910</PMID>
  </results_reference>
  <results_reference>
    <citation>de Jonge RC, Polderman KH, Gemke RJ. Central venous catheter use in the pediatric patient: mechanical and infectious complications. Pediatr Crit Care Med. 2005 May;6(3):329-39. doi: 10.1097/01.PCC.0000161074.94315.0A.</citation>
    <PMID>15857534</PMID>
  </results_reference>
  <results_reference>
    <citation>Karapinar B, Cura A. Complications of central venous catheterization in critically ill children. Pediatr Int. 2007 Oct;49(5):593-9. doi: 10.1111/j.1442-200X.2007.02407.x.</citation>
    <PMID>17875082</PMID>
  </results_reference>
  <results_reference>
    <citation>Casado-Flores J, Barja J, Martino R, Serrano A, Valdivielso A. Complications of central venous catheterization in critically ill children. Pediatr Crit Care Med. 2001 Jan;2(1):57-62. doi: 10.1097/00130478-200101000-00012.</citation>
    <PMID>12797890</PMID>
  </results_reference>
  <results_reference>
    <citation>Richards MJ, Edwards JR, Culver DH, Gaynes RP. Nosocomial infections in medical intensive care units in the United States. National Nosocomial Infections Surveillance System. Crit Care Med. 1999 May;27(5):887-92. doi: 10.1097/00003246-199905000-00020.</citation>
    <PMID>10362409</PMID>
  </results_reference>
  <results_reference>
    <citation>Stenzel JP, Green TP, Fuhrman BP, Carlson PE, Marchessault RP. Percutaneous femoral venous catheterizations: a prospective study of complications. J Pediatr. 1989 Mar;114(3):411-5. doi: 10.1016/s0022-3476(89)80559-1.</citation>
    <PMID>2921683</PMID>
  </results_reference>
  <results_reference>
    <citation>He C, Vieira R, Marin JR. Utility of Ultrasound Guidance for Central Venous Access in Children. Pediatr Emerg Care. 2017 May;33(5):359-362. doi: 10.1097/PEC.0000000000001124.</citation>
    <PMID>28471906</PMID>
  </results_reference>
  <results_reference>
    <citation>Sanchez Sanchez A, Giron Vallejo O, Ruiz-Pruneda R, Fernandez Ibieta M, Reyes Rios PY, Villamil V, Martinez-Castano I, Rojas Ticona J, Gimenez Aleixandre MC, Ruiz Jimenez JI. [Use of ultrasound for placement of central venous catheters in pediatrics: results of a national survey]. Cir Pediatr. 2017 Jan 25;30(1):9-16. Spanish.</citation>
    <PMID>28585784</PMID>
  </results_reference>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>September 12, 2017</study_first_submitted>
  <study_first_submitted_qc>September 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 13, 2017</study_first_posted>
  <last_update_submitted>November 4, 2017</last_update_submitted>
  <last_update_submitted_qc>November 4, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 7, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>IRCCS Policlinico S. Donato</investigator_affiliation>
    <investigator_full_name>Marco Ranucci</investigator_full_name>
    <investigator_title>Director Clinical Research</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Sepsis</mesh_term>
    <mesh_term>Heart Diseases</mesh_term>
    <mesh_term>Heart Defects, Congenital</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The dataset will be made available at reasonable request</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_time_frame>November 2017 - November 2020</ipd_time_frame>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03282292
org study id: PedCVC
nct id: NCT03282292
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized controlled trial
primary purpose: Prevention
masking: None (Open Label)
measure: CVC colonization
time frame: 14 days
description: CVC positive culture after removal
measure: CRBSI
time frame: 14 days
description: Positive CVC culture and blood stream infection for the same organism
measure: CLABSI
time frame: More than 48 hours
description: A laboratory-confirmed bloodstream infection where central line was in place for more than 48h.
measure: Mechanical complications
time frame: 1 day
description: Defined as arterial puncture; hemothorax; pneumothorax
measure: Procedural difficulty
time frame: 1 hour
description: Defined by number of attempts; no guidewire progress
arm group label: Jugular
arm group type: Experimental
description: CVC insertion in the left or right internal jugular vein
arm group label: Femoral
arm group type: Active Comparator
description: CVC insertion in the right or left femoral vein
intervention type: Procedure
intervention name: Internal jugular vein CVC insertion
description: Double lumen CVC insertion in the internal jugular vein
arm group label: Femoral
arm group label: Jugular
criteria: 
gender: All
minimum age: N/A
maximum age: 1 Year
healthy volunteers: No
last name: Marco Ranucci, MD
role: Study Director
affiliation: IRCCS Policlinico S. Donato
last name: Marco Ranucci, MD
phone: +390252774754
email: cardioanestesia@virgilio.it
last name: Simona Silvetti, MD
phone: +390252774754
email: lu.simo@hotmail.it
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
country: Italy
citation: Collignon P, Soni N, Pearson I, Sorrell T, Woods P. Sepsis associated with central vein catheters in critically ill patients. Intensive Care Med. 1988;14(3):227-31. doi: 10.1007/BF00717995.
PMID: 3379183
citation: Pearson ML. Guideline for prevention of intravascular device-related infections. Part I. Intravascular device-related infections: an overview. The Hospital Infection Control Practices Advisory Committee. Am J Infect Control. 1996 Aug;24(4):262-77. doi: 10.1016/s0196-6553(96)90058-9. No abstract available.
PMID: 8870910
citation: de Jonge RC, Polderman KH, Gemke RJ. Central venous catheter use in the pediatric patient: mechanical and infectious complications. Pediatr Crit Care Med. 2005 May;6(3):329-39. doi: 10.1097/01.PCC.0000161074.94315.0A.
PMID: 15857534
citation: Karapinar B, Cura A. Complications of central venous catheterization in critically ill children. Pediatr Int. 2007 Oct;49(5):593-9. doi: 10.1111/j.1442-200X.2007.02407.x.
PMID: 17875082
citation: Casado-Flores J, Barja J, Martino R, Serrano A, Valdivielso A. Complications of central venous catheterization in critically ill children. Pediatr Crit Care Med. 2001 Jan;2(1):57-62. doi: 10.1097/00130478-200101000-00012.
PMID: 12797890
citation: Richards MJ, Edwards JR, Culver DH, Gaynes RP. Nosocomial infections in medical intensive care units in the United States. National Nosocomial Infections Surveillance System. Crit Care Med. 1999 May;27(5):887-92. doi: 10.1097/00003246-199905000-00020.
PMID: 10362409
citation: Stenzel JP, Green TP, Fuhrman BP, Carlson PE, Marchessault RP. Percutaneous femoral venous catheterizations: a prospective study of complications. J Pediatr. 1989 Mar;114(3):411-5. doi: 10.1016/s0022-3476(89)80559-1.
PMID: 2921683
citation: He C, Vieira R, Marin JR. Utility of Ultrasound Guidance for Central Venous Access in Children. Pediatr Emerg Care. 2017 May;33(5):359-362. doi: 10.1097/PEC.0000000000001124.
PMID: 28471906
citation: Sanchez Sanchez A, Giron Vallejo O, Ruiz-Pruneda R, Fernandez Ibieta M, Reyes Rios PY, Villamil V, Martinez-Castano I, Rojas Ticona J, Gimenez Aleixandre MC, Ruiz Jimenez JI. [Use of ultrasound for placement of central venous catheters in pediatrics: results of a national survey]. Cir Pediatr. 2017 Jan 25;30(1):9-16. Spanish.
PMID: 28585784
responsible party type: Principal Investigator
investigator affiliation: IRCCS Policlinico S. Donato
investigator full name: Marco Ranucci
investigator title: Director Clinical Research
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Sepsis
mesh term: Heart Diseases
mesh term: Heart Defects, Congenital
sharing ipd: Yes
ipd description: The dataset will be made available at reasonable request
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd time frame: November 2017 - November 2020