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

Primary Purpose

Central Line-associated Bloodstream Infection (CLABSI), Central Venous Catheter Associated Bloodstream Infection, Heart; Surgery, Heart, Functional Disturbance as Result

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Internal jugular vein CVC insertion
Sponsored by
IRCCS Policlinico S. Donato
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Central Line-associated Bloodstream Infection (CLABSI)

Eligibility Criteria

undefined - 1 Year (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • IRCCS Policlinico S.DonatoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Jugular

Femoral

Arm Description

CVC insertion in the left or right internal jugular vein

CVC insertion in the right or left femoral vein

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Mechanical complications
Defined as arterial puncture; hemothorax; pneumothorax
Procedural difficulty
Defined by number of attempts; no guidewire progress

Full Information

First Posted
September 12, 2017
Last Updated
November 4, 2017
Sponsor
IRCCS Policlinico S. Donato
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1. Study Identification

Unique Protocol Identification Number
NCT03282292
Brief Title
Central Venous Catheter Insertion Site and Colonization in Pediatric Cardiac Surgery
Acronym
PRECiSE
Official Title
Central Venous Catheter Insertion Site and Catheter Colonization and Bloodstream Infection in Pediatric Cardiac Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 12, 2017 (Actual)
Primary Completion Date
September 12, 2019 (Anticipated)
Study Completion Date
October 12, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS Policlinico S. Donato

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Central Line-associated Bloodstream Infection (CLABSI), Central Venous Catheter Associated Bloodstream Infection, Heart; Surgery, Heart, Functional Disturbance as Result, Congenital Heart Disease, Newborn; Infection

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Jugular
Arm Type
Experimental
Arm Description
CVC insertion in the left or right internal jugular vein
Arm Title
Femoral
Arm Type
Active Comparator
Arm Description
CVC insertion in the right or left femoral vein
Intervention Type
Procedure
Intervention Name(s)
Internal jugular vein CVC insertion
Intervention Description
Double lumen CVC insertion in the internal jugular vein
Primary Outcome Measure Information:
Title
CVC colonization
Description
CVC positive culture after removal
Time Frame
14 days
Title
CRBSI
Description
Positive CVC culture and blood stream infection for the same organism
Time Frame
14 days
Title
CLABSI
Description
A laboratory-confirmed bloodstream infection where central line was in place for more than 48h.
Time Frame
More than 48 hours
Secondary Outcome Measure Information:
Title
Mechanical complications
Description
Defined as arterial puncture; hemothorax; pneumothorax
Time Frame
1 day
Title
Procedural difficulty
Description
Defined by number of attempts; no guidewire progress
Time Frame
1 hour

10. Eligibility

Sex
All
Maximum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marco Ranucci, MD
Phone
+390252774754
Email
cardioanestesia@virgilio.it
First Name & Middle Initial & Last Name or Official Title & Degree
Simona Silvetti, MD
Phone
+390252774754
Email
lu.simo@hotmail.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marco Ranucci, MD
Organizational Affiliation
IRCCS Policlinico S. Donato
Official's Role
Study Director
Facility Information:
Facility Name
IRCCS Policlinico S.Donato
City
San Donato Milanese
State/Province
Milan
ZIP/Postal Code
20097
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marco Ranucci, MD
Phone
00390252774
Ext
754
Email
cardioanestesia@virgilio.it
First Name & Middle Initial & Last Name & Degree
Marco Ranucci, MD
First Name & Middle Initial & Last Name & Degree
Simona Silvetti, MD
First Name & Middle Initial & Last Name & Degree
Tommaso Aloisio, MD
First Name & Middle Initial & Last Name & Degree
Anna Cazzaniga, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The dataset will be made available at reasonable request
IPD Sharing Time Frame
November 2017 - November 2020
Citations:
PubMed Identifier
3379183
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.
Results Reference
result
PubMed Identifier
8870910
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.
Results Reference
result
PubMed Identifier
15857534
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.
Results Reference
result
PubMed Identifier
17875082
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.
Results Reference
result
PubMed Identifier
12797890
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.
Results Reference
result
PubMed Identifier
10362409
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.
Results Reference
result
PubMed Identifier
2921683
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.
Results Reference
result
PubMed Identifier
28471906
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.
Results Reference
result
PubMed Identifier
28585784
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.
Results Reference
result
PubMed Identifier
29941012
Citation
Silvetti S, Aloisio T, Cazzaniga A, Ranucci M. Jugular vs femoral vein for central venous catheterization in pediatric cardiac surgery (PRECiSE): study protocol for a randomized controlled trial. Trials. 2018 Jun 25;19(1):329. doi: 10.1186/s13063-018-2717-1.
Results Reference
derived

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Central Venous Catheter Insertion Site and Colonization in Pediatric Cardiac Surgery

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