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

Sponsor

University Hospital, Caen (Other)

Overall Status

Completed

CT.gov ID

NCT00277888

Collaborator

(none)

750

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Kidney Failure, Acute Critical Illness	Procedure: Femoral route for hemodialysis Procedure: Jugular route for hemodialysis	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

750 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Apr 1, 2004

Actual Primary Completion Date :

May 1, 2007

Actual Study Completion Date :

May 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Femoral route	Procedure: Femoral route for hemodialysis
Experimental: Jugular route	Procedure: Jugular route for hemodialysis

Arm

Intervention/Treatment

Experimental: Femoral route

Procedure: Femoral route for hemodialysis

Experimental: Jugular route

Procedure: Jugular route for hemodialysis

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	Country	Postal Code
1	Medical and nephrologic Intensive Care Unit, CHU Amien Sud	Amiens	France	80000
2	CH Argenteuil	Argenteuil	France	95100
3	Medical Intensive Care Unit, CHU de Caen	Caen	France	14000
4	Surgical Intensive Care Unit	Caen	France	14033
5	CHU de Clermont Ferrand	Clermont Ferrand	France
6	CHU Raymond Pointcarré	Garches	France	92380
7	Hôpital Cochin	Paris	France	75679
8	Hôpital Lariboisière	Paris	France	75
9	Hôpital St Joseph	Paris	France	75
10	CH Saint Malo	Saint Malo	France