Critical Illness Clinical Trial
— CATHEDIAOfficial title:
Complications of Jugular and Femoral Venous Catheterization in Critically Ill Patients Requiring Hemodialysis: A Randomized Controlled Trial
| Verified date | November 2014 |
| Source | University Hospital, Caen |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | France: Institutional Ethical Committee |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 750 |
| Est. completion date | May 2007 |
| Est. primary completion date | May 2007 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| France | Medical and nephrologic Intensive Care Unit, CHU Amien Sud | Amiens | |
| France | CH Argenteuil | Argenteuil | |
| France | Medical Intensive Care Unit, CHU de Caen | Caen | |
| France | Surgical Intensive Care Unit | Caen | |
| France | CHU de Clermont Ferrand | Clermont Ferrand | |
| France | CHU Raymond Pointcarré | Garches | |
| France | Hôpital Cochin | Paris | |
| France | Hôpital Lariboisière | Paris | |
| France | Hôpital St Joseph | Paris | |
| France | CH Saint Malo | Saint Malo |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Caen |
France,
Dugué 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: 10.2 — View Citation
Parienti JJ, Deryckère S, Mégarbane 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 amo — View Citation
Parienti JJ, Dugué AE, Daurel C, Mira JP, Mégarbane 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. — View Citation
Parienti JJ, Mégarbane 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 critical — View Citation
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 — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Time of insertion without complication | |||
| Secondary | Rates of mechanical complications | |||
| Secondary | Rates of infectious complications including cath-colonization | |||
| Secondary | Quality of hemodialysis by urea extraction ratio |
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