Comparison of Femoral Versus Jugular Routes for Temporary Hemodialysis in Seriously Ill Patients - Full Text View

Sponsor:	University Hospital, Caen
Information provided by:	University Hospital, Caen
ClinicalTrials.gov Identifier:	NCT00277888

Purpose

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.

Condition	Intervention
Kidney Failure, Acute Critical Illness	Procedure: Femoral route for hemodialysis Procedure: Jugular route for hemodialysis

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Complications of Jugular and Femoral Venous Catheterization in Critically Ill Patients Requiring Hemodialysis: A Randomized Controlled Trial

Resource links provided by NLM:

MedlinePlus related topics: Dialysis

U.S. FDA Resources

Further study details as provided by University Hospital, Caen:

Primary Outcome Measures:

Time of insertion without complication

Secondary Outcome Measures:

Rates of mechanical complications
Rates of infectious complications including cath-colonization
Quality of hemodialysis by urea extraction ratio

Enrollment:	750
Study Start Date:	April 2004
Study Completion Date:	May 2007
Primary Completion Date:	May 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Femoral route	Procedure: Femoral route for hemodialysis
Experimental: Jugular route	Procedure: Jugular route for hemodialysis

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00277888

Locations

France
Medical and nephrologic Intensive Care Unit, CHU Amien Sud
Amiens, France, 80000
CH Argenteuil
Argenteuil, France, 95100
Medical Intensive Care Unit, CHU de Caen
Caen, France, 14000
Surgical Intensive Care Unit
Caen, France, 14033
CHU de Clermont Ferrand
Clermont Ferrand, France
CHU Raymond Pointcarré
Garches, France, 92380
Hôpital St Joseph
Paris, France, 75
Hôpital Lariboisière
Paris, France, 75
Hôpital Cochin
Paris, France, 75679
CH Saint Malo
Saint Malo, France

Sponsors and Collaborators

University Hospital, Caen

Investigators

Principal Investigator:

Jean-Jacques Parienti, MD

University Hospital, Caen

More Information

Additional Information:

Literature summary of central venous catheter complications This link exits the ClinicalTrials.gov site

Guidelines for the prevention of intravascular catheter-related infections This link exits the ClinicalTrials.gov site

Publications:

Parienti JJ, Thirion M, Mégarbane B, Souweine B, Ouchikhe A, Polito A, Forel JM, Marqué 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.

Parienti JJ, Mégarbane 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.

Parienti JJ, Dugué AE, Daurel C, Mira JP, Mégarbane 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. Epub 2010 Jun 17.

Dugué AE, Levesque SP, Fischer MO, Souweine B, Mira JP, Megarbane B, Daubin C, du Cheyron D, Parienti JJ; for the Cathedia Study Group. Vascular Access Sites for Acute Renal Replacement in Intensive Care Units. Clin J Am Soc Nephrol. 2011 Nov 10; [Epub ahead of print]

ClinicalTrials.gov Identifier:	NCT00277888 History of Changes
Other Study ID Numbers:	PHRC-Cathedia
Study First Received:	January 13, 2006
Last Updated:	November 22, 2011
Health Authority:	France: Institutional Ethical Committee

Keywords provided by University Hospital, Caen:

Dialysis
Hemodialysis
Catheterization

Additional relevant MeSH terms:

Critical Illness
Acute Kidney Injury
Renal Insufficiency
Disease Attributes

Pathologic Processes
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on February 12, 2012