CITrate and Evodial for Effective Dialysis (CITED) Study
CITED
1 other identifier
interventional
25
1 country
2
Brief Summary
It is not known whether the combination of a heparin-grafted membrane plus citrate-containing dialysate is a valid alternative to regional citrate anticoagulation. This is a cross-over non-inferiority trial comparing these two anticoagulation strategies
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2014
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 22, 2014
CompletedFirst Posted
Study publicly available on registry
November 3, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedMay 13, 2016
October 1, 2014
7 months
October 22, 2014
May 12, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Patency of hemodialysis circuit
Completion of 4h dialysis session without circuit clotting that requires early treatment interruption
20 weeks
Secondary Outcomes (1)
Clotting of dialyser after the rinse
20 weeks
Study Arms (2)
EVODIAL dialyzer and Selectbag citrate
EXPERIMENTALIntervention for anticoagulation during dialysis: Combination of Heparin-coated AN69ST membrane (EVODIAL, Gambro-Hospal, Meyzieu, France) and citrate-containing dialysate (Selectbag citrate, Gambro, Lund, Sweden).
Regional citrate anticoagulation
ACTIVE COMPARATORRegional citrate anticoagulation, using a hypertonic sterile solution of trisodium citrate dihydrate (1.035 Mol/L, Baxter, Lessines, Belgium), infused into the afferent blood line. Citrate will be infused at a rate of 62.1 mM/h (60 mL/h). The anticoagulant effect of citrate will be neutralized using calcium containing dialysate (Ca 1.50 mmol/L). Dialysate sodium content will be set at 135 mEQ/L, and bicarbonate will be reduced to 25 mEq/L.
Interventions
Evodial is a trademark of Hospal-Gambro.
Regional citrate anticoagulation is performed according to local practice, using a calcium-containing dialysate
Eligibility Criteria
You may qualify if:
- Patients aged over 18 years,
- hemodynamic stability,
- hemoglobin 9 - 12 g/dl.
You may not qualify if:
- Any hemostatic disorder favoring either bleeding or clotting,
- anti-vitamin K treatment,
- risk of bleeding according to the criteria of Swartz (12).
- All vascular access types (AV-fistula, AV graft, catheter) are allowed. However, only patients with double route vascular access ('bipuncture') will be included in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Universitaire Ziekenhuizen Leuven
Leuven, Vlaams-Brabant, 3000, Belgium
University Hospitals Leuven
Leuven, 3000, Belgium
Related Publications (1)
Natale P, Palmer SC, Ruospo M, Longmuir H, Dodds B, Prasad R, Batt TJ, Jose MD, Strippoli GF. Anticoagulation for people receiving long-term haemodialysis. Cochrane Database Syst Rev. 2024 Jan 8;1(1):CD011858. doi: 10.1002/14651858.CD011858.pub2.
PMID: 38189593DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Björn Meijers, MD, PhD
UZ Leuven
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 22, 2014
First Posted
November 3, 2014
Study Start
October 1, 2014
Primary Completion
May 1, 2015
Study Completion
May 1, 2015
Last Updated
May 13, 2016
Record last verified: 2014-10
Data Sharing
- IPD Sharing
- Will not share