Central Venous Catheter Insertion Site and Colonization in Pediatric Cardiac Surgery

Congenital Heart Disease Clinical Trial

— PRECiSE  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03282292
• Other study ID #: PedCVC
• Status: Withdrawn
• Phase: N/A
• Start date: September 12, 2017
• Est. completion date: October 12, 2019

Study information

• Verified date: November 2023
• Source: IRCCS Policlinico S. Donato
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 12, 2019
• Est. primary completion date: September 12, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 1 Year

Eligibility

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.

Related Conditions & MeSH terms

• Central Line-associated Bloodstream Infection (CLABSI)
• Central Venous Catheter Associated Bloodstream Infection
• Communicable Diseases
• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases
• Heart; Surgery, Heart, Functional Disturbance as Result
• Infections
• Newborn; Infection
• Sepsis

Intervention

Procedure:
• Internal jugular vein CVC insertion
Double lumen CVC insertion in the internal jugular vein

Locations

Country	Name	City	State
Italy	IRCCS Policlinico S.Donato	San Donato Milanese	Milan

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Policlinico S. Donato

Country where clinical trial is conducted

Italy, 

References & Publications (9)

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. — View 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. — View 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. — View 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. — View 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. — View 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 — View 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. — View 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: resu — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CVC colonization	CVC positive culture after removal	14 days
Primary	CRBSI	Positive CVC culture and blood stream infection for the same organism	14 days
Primary	CLABSI	A laboratory-confirmed bloodstream infection where central line was in place for more than 48h.	More than 48 hours
Secondary	Mechanical complications	Defined as arterial puncture; hemothorax; pneumothorax	1 day
Secondary	Procedural difficulty	Defined by number of attempts; no guidewire progress	1 hour