Clinical trial NCT00277888: Comparison of Femoral Versus Jugular Routes for Temporary Hemodialysis in Seriously Ill Patients
Official title: Complications of Jugular and Femoral Venous Catheterization in Critically Ill Patients Requiring Hemodialysis: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Failure, Acute
Critical Illness
Keywords: Dialysis
Hemodialysis
Catheterization
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2006-01-18
Enrollment: 750
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: The purpose of this study is to determine whether a jugular route leads to a lower rate of complications as compared with a femoral route for catheterization in patients admitted in several intensive care units in France who develop acute renal failure requiring hemodiafiltration or hemodialysis.


Eligibility criteria: Inclusion Criteria:

* Admitted in intensive care unit (ICU)
* Requiring hemodialysis
* Clinicians have the choice between jugular and femoral routes

Exclusion Criteria:

* Chronic renal failure requiring long term dialysis

Primary outcomes:
measure: Time of insertion without complication
Secondary outcomes:
measure: Rates of mechanical complications
measure: Rates of infectious complications including cath-colonization
measure: Quality of hemodialysis by urea extraction ratio
Other outcomes:
Locations:
city: Amiens
country: France
facility: Medical and nephrologic Intensive Care Unit, CHU Amien Sud
city: Argenteuil
country: France
facility: CH Argenteuil
city: Caen
country: France
facility: Medical Intensive Care Unit, CHU de Caen
city: Caen
country: France
facility: Surgical Intensive Care Unit
city: Clermont Ferrand
country: France
facility: CHU de Clermont Ferrand
city: Garches
country: France
facility: CHU Raymond Pointcarré
city: Paris
country: France
facility: Hôpital Cochin
city: Paris
country: France
facility: Hôpital Lariboisière
city: Paris
country: France
facility: Hôpital St Joseph
city: Saint Malo
country: France
facility: CH Saint Malo
Study officials:
affiliation: University Hospital, Caen
name: Jean-Jacques Parienti, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Parienti JJ, Thirion M, Megarbane B, Souweine B, Ouchikhe A, Polito A, Forel JM, Marque S, Misset B, Airapetian N, Daurel C, Mira JP, Ramakers M, du Cheyron D, Le Coutour X, Daubin C, Charbonneau P; Members of the Cathedia Study Group. Femoral vs jugular venous catheterization and risk of nosocomial events in adults requiring acute renal replacement therapy: a randomized controlled trial. JAMA. 2008 May 28;299(20):2413-22. doi: 10.1001/jama.299.20.2413.
citation: Parienti JJ, Megarbane B, Fischer MO, Lautrette A, Gazui N, Marin N, Hanouz JL, Ramakers M, Daubin C, Mira JP, Charbonneau P, du Cheyron D; Cathedia Study Group. Catheter dysfunction and dialysis performance according to vascular access among 736 critically ill adults requiring renal replacement therapy: a randomized controlled study. Crit Care Med. 2010 Apr;38(4):1118-25. doi: 10.1097/CCM.0b013e3181d454b3.
citation: Parienti JJ, Dugue AE, Daurel C, Mira JP, Megarbane B, Mermel LA, Daubin C, du Cheyron D; Members of the Cathedia Study Group. Continuous renal replacement therapy may increase the risk of catheter infection. Clin J Am Soc Nephrol. 2010 Aug;5(8):1489-96. doi: 10.2215/CJN.02130310. Epub 2010 Jun 17.
citation: Dugue AE, Levesque SP, Fischer MO, Souweine B, Mira JP, Megarbane B, Daubin C, du Cheyron D, Parienti JJ; Cathedia Study Group. Vascular access sites for acute renal replacement in intensive care units. Clin J Am Soc Nephrol. 2012 Jan;7(1):70-7. doi: 10.2215/CJN.06570711. Epub 2011 Nov 10.
citation: Parienti JJ, Deryckere S, Megarbane B, Valette X, Seguin A, Sauneuf B, Mira JP, Souweine B, Cattoir V, Daubin C, du Cheyron D; Cathedia Study Group. Quasi-experimental study of sodium citrate locks and the risk of acute hemodialysis catheter infection among critically ill patients. Antimicrob Agents Chemother. 2014 Oct;58(10):5666-72. doi: 10.1128/AAC.03079-14. Epub 2014 Jun 30.
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.
citation: Tsujimoto Y, Miki S, Shimada H, Tsujimoto H, Yasuda H, Kataoka Y, Fujii T. Non-pharmacological interventions for preventing clotting of extracorporeal circuits during continuous renal replacement therapy. Cochrane Database Syst Rev. 2021 Sep 14;9(9):CD013330. doi: 10.1002/14651858.CD013330.pub2.