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

Central Venous Catheter Insertion Site and Catheter Colonization and Bloodstream Infection in Pediatric Cardiac Surgery

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.

Study Overview

• Status: Withdrawn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

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: Interventional
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marco Ranucci, MD; Phone Number: +390252774754; Email: cardioanestesia@virgilio.it
• Study Contact Backup: Name: Simona Silvetti, MD; Phone Number: +390252774754; Email: lu.simo@hotmail.it

Study Locations

• Italy
  • Milan
    • San Donato Milanese, Milan, Italy, 20097
      • IRCCS Policlinico S.Donato

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 year (Child)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mechanical complications	Defined as arterial puncture; hemothorax; pneumothorax	1 day
Procedural difficulty	Defined by number of attempts; no guidewire progress	1 hour

Collaborators and Investigators

• Sponsor: IRCCS Policlinico S. Donato
• Investigators: Study Director: Marco Ranucci, MD, IRCCS Policlinico S. Donato

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2017
• Primary Completion (Actual): September 12, 2019
• Study Completion (Actual): October 12, 2019

Study Registration Dates

• First Submitted: September 12, 2017
• First Submitted That Met QC Criteria: September 12, 2017
• First Posted (Actual): September 13, 2017

Study Record Updates

• Last Update Posted (Estimated): November 17, 2023
• Last Update Submitted That Met QC Criteria: November 16, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Systemic Inflammatory Response Syndrome; Inflammation; Disease Attributes; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Diseases; Sepsis; Infections; Communicable Diseases; Heart Defects, Congenital
• Other Study ID Numbers: PedCVC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The dataset will be made available at reasonable request
• IPD Sharing Time Frame: November 2017 - November 2020
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No