NCT00277888

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
750

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2004

Typical duration for not_applicable

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

January 13, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 18, 2006

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

November 14, 2014

Status Verified

November 1, 2014

Enrollment Period

3.1 years

First QC Date

January 13, 2006

Last Update Submit

November 13, 2014

Conditions

Keywords

DialysisHemodialysisCatheterization

Outcome Measures

Primary Outcomes (1)

  • Time of insertion without complication

Secondary Outcomes (3)

  • Rates of mechanical complications

  • Rates of infectious complications including cath-colonization

  • Quality of hemodialysis by urea extraction ratio

Study Arms (2)

Femoral route

EXPERIMENTAL
Procedure: Femoral route for hemodialysis

Jugular route

EXPERIMENTAL
Procedure: Jugular route for hemodialysis

Interventions

Femoral route
Jugular route

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Admitted in intensive care unit (ICU)
  • Requiring hemodialysis
  • Clinicians have the choice between jugular and femoral routes

You may not qualify if:

  • Chronic renal failure requiring long term dialysis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Medical and nephrologic Intensive Care Unit, CHU Amien Sud

Amiens, 80000, France

Location

CH Argenteuil

Argenteuil, 95100, France

Location

Medical Intensive Care Unit, CHU de Caen

Caen, 14000, France

Location

Surgical Intensive Care Unit

Caen, 14033, France

Location

CHU de Clermont Ferrand

Clermont-Ferrand, France

Location

CHU Raymond Pointcarré

Garches, 92380, France

Location

Hôpital Cochin

Paris, 75679, France

Location

Hôpital Lariboisière

Paris, 75, France

Location

Hôpital St Joseph

Paris, 75, France

Location

CH Saint Malo

St-Malo, France

Location

Related Publications (7)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

Related Links

MeSH Terms

Conditions

Acute Kidney InjuryCritical Illness

Interventions

Renal Dialysis

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Renal Replacement TherapyTherapeuticsSorption Detoxification

Study Officials

  • Jean-Jacques Parienti, MD

    University Hospital, Caen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 13, 2006

First Posted

January 18, 2006

Study Start

April 1, 2004

Primary Completion

May 1, 2007

Study Completion

May 1, 2007

Last Updated

November 14, 2014

Record last verified: 2014-11

Locations