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

Primary Purpose

Kidney Failure, Acute, Critical Illness

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Femoral route for hemodialysis
Jugular route for hemodialysis
Sponsored by
University Hospital, Caen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Kidney Failure, Acute focused on measuring Dialysis, Hemodialysis, Catheterization

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Medical and nephrologic Intensive Care Unit, CHU Amien Sud
  • CH Argenteuil
  • Medical Intensive Care Unit, CHU de Caen
  • Surgical Intensive Care Unit
  • CHU de Clermont Ferrand
  • CHU Raymond Pointcarré
  • Hôpital Cochin
  • Hôpital Lariboisière
  • Hôpital St Joseph
  • CH Saint Malo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Femoral route

Jugular route

Arm Description

Outcomes

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

Full Information

First Posted
January 13, 2006
Last Updated
November 13, 2014
Sponsor
University Hospital, Caen
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1. Study Identification

Unique Protocol Identification Number
NCT00277888
Brief Title
Comparison of Femoral Versus Jugular Routes for Temporary Hemodialysis in Seriously Ill Patients
Acronym
CATHEDIA
Official Title
Complications of Jugular and Femoral Venous Catheterization in Critically Ill Patients Requiring Hemodialysis: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
May 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Caen

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Failure, Acute, Critical Illness
Keywords
Dialysis, Hemodialysis, Catheterization

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
750 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Femoral route
Arm Type
Experimental
Arm Title
Jugular route
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Femoral route for hemodialysis
Intervention Type
Procedure
Intervention Name(s)
Jugular route for hemodialysis
Primary Outcome Measure Information:
Title
Time of insertion without complication
Secondary Outcome Measure Information:
Title
Rates of mechanical complications
Title
Rates of infectious complications including cath-colonization
Title
Quality of hemodialysis by urea extraction ratio

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Jacques Parienti, MD
Organizational Affiliation
University Hospital, Caen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical and nephrologic Intensive Care Unit, CHU Amien Sud
City
Amiens
ZIP/Postal Code
80000
Country
France
Facility Name
CH Argenteuil
City
Argenteuil
ZIP/Postal Code
95100
Country
France
Facility Name
Medical Intensive Care Unit, CHU de Caen
City
Caen
ZIP/Postal Code
14000
Country
France
Facility Name
Surgical Intensive Care Unit
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
CHU de Clermont Ferrand
City
Clermont Ferrand
Country
France
Facility Name
CHU Raymond Pointcarré
City
Garches
ZIP/Postal Code
92380
Country
France
Facility Name
Hôpital Cochin
City
Paris
ZIP/Postal Code
75679
Country
France
Facility Name
Hôpital Lariboisière
City
Paris
ZIP/Postal Code
75
Country
France
Facility Name
Hôpital St Joseph
City
Paris
ZIP/Postal Code
75
Country
France
Facility Name
CH Saint Malo
City
Saint Malo
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
18505951
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.
Results Reference
result
PubMed Identifier
20154599
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.
Results Reference
result
PubMed Identifier
20558562
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.
Results Reference
result
PubMed Identifier
22076877
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.
Results Reference
result
PubMed Identifier
24982071
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.
Results Reference
result
PubMed Identifier
35799302
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.
Results Reference
derived
PubMed Identifier
34519356
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.
Results Reference
derived
Links:
URL
http://www.cdc.gov/mmwr/PDF/rr/rr5110.pdf
Description
Guidelines for the prevention of intravascular catheter-related infections

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

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