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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00277888
Recruitment Status : Completed
First Posted : January 18, 2006
Last Update Posted : November 14, 2014
Sponsor:
Information provided by:
University Hospital, Caen

Tracking Information
First Submitted Date  ICMJE January 13, 2006
First Posted Date  ICMJE January 18, 2006
Last Update Posted Date November 14, 2014
Study Start Date  ICMJE April 2004
Actual Primary Completion Date May 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 27, 2006)
Time of insertion without complication
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00277888 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 1, 2006)
  • Rates of mechanical complications
  • Rates of infectious complications including cath-colonization
  • Quality of hemodialysis by urea extraction ratio
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Kidney Failure, Acute
  • Critical Illness
Intervention  ICMJE
  • Procedure: Femoral route for hemodialysis
  • Procedure: Jugular route for hemodialysis
Study Arms  ICMJE
  • Experimental: Femoral route
    Intervention: Procedure: Femoral route for hemodialysis
  • Experimental: Jugular route
    Intervention: Procedure: Jugular route for hemodialysis
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 27, 2006)
750
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE May 2007
Actual 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00277888
Other Study ID Numbers  ICMJE PHRC-Cathedia
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE University Hospital, Caen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jean-Jacques Parienti, MD University Hospital, Caen
PRS Account University Hospital, Caen
Verification Date November 2014

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