Central Venous Catheter Insertion Site and Colonization in Pediatric Cardiac Surgery

NCT03282292 | Withdrawn DMC

• 1 other identifier: PedCVC
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Mechanical complications

  1 day

• Procedural difficulty

  1 hour

Study Arms (2)

Jugular

EXPERIMENTAL

CVC insertion in the left or right internal jugular vein

Procedure: Internal jugular vein CVC insertion

Femoral

ACTIVE COMPARATOR

CVC insertion in the right or left femoral vein

Procedure: Internal jugular vein CVC insertion

Interventions

Internal jugular vein CVC insertion PROCEDURE

Double lumen CVC insertion in the internal jugular vein

Femoral; Jugular

Eligibility Criteria

• Age: Up to 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• IRCCS Policlinico S. Donato: lead

Study Sites (1)

IRCCS Policlinico S.Donato

San Donato Milanese, Milan, 20097, Italy

Location

Related Publications (10)

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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.

  PMID: 29941012 DERIVED

MeSH Terms

Conditions

Heart Defects, Congenital; Infections

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Marco Ranucci, MD

  IRCCS Policlinico S. Donato

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Clinical Research

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: September 12, 2017
• First Posted: September 13, 2017
• Study Start: September 12, 2017
• Primary Completion: September 12, 2019
• Study Completion: October 12, 2019
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: November 2017 - November 2020

Locations

IT (1)