Citrate Versus Heparin for the Lock of Non-tunneled Hemodialysis Catheters in Patients Hospitalised in ICU
NCT ID: NCT01962116
Last Updated: 2018-08-15
Study Results
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Basic Information
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COMPLETED
PHASE3
405 participants
INTERVENTIONAL
2013-06-14
2016-12-31
Brief Summary
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* The first group will have a citrate lock
* The second group will have a heparin lock Patients will be stratified according to the centre and type of Renal Replacement Therapy (RRT) continuous or intermittent.
The daily surveillance of patients will not be different from the usual surveillance of patients on Renal Replacement Therapy.
The hemodialysis catheters used will be specific Renal Replacement Therapy catheters.
The decision to withdraw the catheter will be made by the investigator and based on clinical criteria (complications related to the catheter, termination of Renal Replacement Therapy…)
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Heparin lock
unfractionated heparin
Citrate lock
Citrate 4%
Interventions
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Citrate 4%
unfractionated heparin
Eligibility Criteria
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Inclusion Criteria
* Requiring RRT for acute renal insufficiency
* For which a 1st non-tunneled catheter is placed
* In the jugular or femoral position
* After written informed consent has been obtained from the patient, a member of the family or a person of trust
Exclusion Criteria
* Known allergy to citrate
* Acute liver failure (Prothrombin level \<30%)
* Thrombopenia \< 30 000/mm3
* Known or suspected heparin-induced thrombopenia
* Known systemic bacterial infection at the time the catheter is placed
* catheter in the subclavicular position
* Persons not affiliated to a national health insurance scheme
* Pregnant women
* Adults under guardianship
18 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire Dijon
OTHER
Responsible Party
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Locations
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CHU Dijon
Dijon, , France
Countries
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References
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Tsujimoto H, Tsujimoto Y, Nakata Y, Fujii T, Takahashi S, Akazawa M, Kataoka Y. Pharmacological interventions for preventing clotting of extracorporeal circuits during continuous renal replacement therapy. Cochrane Database Syst Rev. 2020 Dec 14;12(12):CD012467. doi: 10.1002/14651858.CD012467.pub3.
Quenot JP, Helms J, Bourredjem A, Dargent A, Meziani F, Badie J, Blasco G, Piton G, Capellier G, Mezher C, Rebibou JM, Nadji A, Crepin T, Barbar SD, Fleck C, Cransac A, Boulin M, Binquet C, Soudry-Faure A, Bruyere R; VERROU-REA Trial Investigators and the CRICS TRIGGERSEP Group (Clinical Research in Intensive Care and Sepsis Trial Group for Global Evaluation and Research in Sepsis). Trisodium citrate 4% versus heparin as a catheter lock for non-tunneled hemodialysis catheters in critically ill patients: a multicenter, randomized clinical trial. Ann Intensive Care. 2019 Jul 1;9(1):75. doi: 10.1186/s13613-019-0553-4.
Bruyere R, Soudry-Faure A, Capellier G, Binquet C, Nadji A, Torner S, Blasco G, Yannaraki M, Barbar SD, Quenot JP. Comparison of heparin to citrate as a catheter locking solution for non-tunneled central venous hemodialysis catheters in patients requiring renal replacement therapy for acute renal failure (VERROU-REA study): study protocol for a randomized controlled trial. Trials. 2014 Nov 19;15:449. doi: 10.1186/1745-6215-15-449.
Other Identifiers
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QUENOT DB 2012
Identifier Type: -
Identifier Source: org_study_id
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