Clinical trial NCT01479153: Venous Site for Central Catheterization
Official title: Comparison of Subclavian, Femoral and Internal Jugular Venous Catheterization in Term of Complications in the Intensive Care Unit: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Care
Catheterization
ICU
Keywords: Central venous catheterization
Major complications
Internal Jugular
Femoral
Subclavian
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2011-11-24
Enrollment: 3471
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Central venous catheters are needed in the critical care setting to administer drugs. Three sites are available to gain vascular access: subclavian, internal jugular and femoral. Each site has complications, but there is no randomized controlled study which compared the 3 sites.

The investigators hypothesis is that subclavian catheterization reduces the risk of major complications compared to internal jugular or femoral.


Eligibility criteria: Inclusion Criteria:

* Patient admitted in the Intensive Care Unit
* Requiring Central Venous Catheterization

Exclusion Criteria:

* Patients with only one site available

Primary outcomes:
measure: Major complications including catheter-related bloodstream infection
timeFrame: From central catheter insertion to 48-h after removal
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: Medical Intensive Care Unit, CHU Caen
city: Caen
country: France
facility: Surgical Intensive Care Unit, CHU Caen
city: Paris
country: France
facility: Medical Intensive Care Unit, Cochin, AP-HP
city: Paris
country: France
facility: Médical Intensive Care Unit, Lariboisière, AP-HP
city: Saint Lô
country: France
facility: Polyvalent Intensive Care Unit, Mémorial France Etats-Unis
Study officials:
affiliation: CHU CAEN
name: Jean-Jacques Parienti, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Parienti JJ, Mongardon N, Megarbane B, Mira JP, Kalfon P, Gros A, Marque S, Thuong M, Pottier V, Ramakers M, Savary B, Seguin A, Valette X, Terzi N, Sauneuf B, Cattoir V, Mermel LA, du Cheyron D; 3SITES Study Group. Intravascular Complications of Central Venous Catheterization by Insertion Site. N Engl J Med. 2015 Sep 24;373(13):1220-9. doi: 10.1056/NEJMoa1500964.
citation: Pages J, Hazera P, Megarbane B, du Cheyron D, Thuong M, Dutheil JJ, Valette X, Fournel F, Mermel LA, Mira JP, Daubin C, Parienti JJ; 3SITES Study Group. Comparison of alcoholic chlorhexidine and povidone-iodine cutaneous antiseptics for the prevention of central venous catheter-related infection: a cohort and quasi-experimental multicenter study. Intensive Care Med. 2016 Sep;42(9):1418-26. doi: 10.1007/s00134-016-4406-4. Epub 2016 Jun 16.
citation: Iachkine J, Buetti N, de Grooth HJ, Briant AR, Mimoz O, Megarbane B, Mira JP, Ruckly S, Souweine B, du Cheyron D, Mermel LA, Timsit JF, Parienti JJ. Development and validation of a multivariable prediction model of central venous catheter-tip colonization in a cohort of five randomized trials. Crit Care. 2022 Jul 7;26(1):205. doi: 10.1186/s13054-022-04078-x.