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

Tracking Information

First Received Date ^ICMJE

January 13, 2006

Last Updated Date

October 16, 2008

Start Date ^ICMJE

April 2004

Primary Completion Date

May 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Time of insertion without complication

Original Primary Outcome Measures ^ICMJE

Time of insersion without complication

Change History

Complete list of historical versions of study NCT00277888 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Comparison of Femoral Versus Jugular Routes for Temporary Hemodialysis in Seriously Ill Patients

Official Title ^ICMJE

Complications of Jugular and Femoral Venous Catheterization in Critically Ill Patients Requiring Hemodialysis: A Randomized Controlled Trial

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.

Detailed Description

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Kidney Failure, Acute
Critical Illness

Intervention ^ICMJE

Procedure: Femoral route for hemodialysis
Procedure: Jugular route for hemodialysis

Study Arms / Comparison Groups

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

750

Completion Date

May 2007

Primary Completion Date

May 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France

Administrative Information

NCT ID ^ICMJE

NCT00277888

Responsible Party

Study ID Numbers ^ICMJE

PHRC-Cathedia

Study Sponsor ^ICMJE

University Hospital, Caen

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Jean-Jacques Parienti, MD

University Hospital, Caen

Information Provided By

University Hospital, Caen

Verification Date

October 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP