Application of Citrate Dialysate in Chronic Haemodialysis
2 other identifiers
interventional
95
1 country
4
Brief Summary
Study investigating the safety and efficacy of the citrate dialysis solution compared to standard acetate dialysis solution. Use of citrate dialysis solution is not associated with a clinically relevant development of adverse events. It is hypothesized that citrate dialysate may provide a local anticoagulation effect in the dialyser improving removal of uremic toxins.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2011
Typical duration for not_applicable
4 active sites
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
October 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 20, 2011
CompletedFirst Posted
Study publicly available on registry
February 14, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedJune 6, 2014
June 1, 2014
1.5 years
October 20, 2011
June 5, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Occurrence of clinically relevant calcium disturbances
during or post-dialysis hypocalcaemia with ionized Ca ≤ 0.9 mmol/l
patients are followed for 8 weeks
Occurrence of clinically relevant acid-base disturbances
during or post-dialysis severe alkalosis with pH ≥ 7.55
patients are followed for 8 weeks
Secondary Outcomes (4)
Occurrence of clinically relevant acid-base disturbances
patients are followed for 8 weeks
Occurrence of clinically relevant acid-base disturbances
patients are followed for 8 weeks
Occurrence of clinically relevant intradialytic complications (adverse events)
patients are followed for 8 weeks
Occurrence of clinically relevant adverse events
patients are followed for 8 weeks
Study Arms (6)
HD treated with standard dialysate
ACTIVE COMPARATORpost-dilution oHDF with standard dialysate
ACTIVE COMPARATORpre-dilution oHDF with citrate dialysate
EXPERIMENTALHD treated with citrate dialysate
EXPERIMENTALpost-dilution oHDF with citrate dialysate
EXPERIMENTALpre-dilution oHDF with standard dialysate
ACTIVE COMPARATORInterventions
Use during chronic dialysis 3x/week
Use during chronic dialysis 3x/week
Eligibility Criteria
You may qualify if:
- signed informed consent
- patients of either sex aged ≥ 18 years
- stable chronic dialysis patients undergoing a 3x/week high-flux dialysis for at least three months
- patients without planned or predictable changes within diet, anticoagulation and medication regimen
You may not qualify if:
- pregnancy or lactation or woman in child bearing age without effective contraception
- planned surgeries or hospital stay within the next 9 weeks
- use of catheter as vascular access for dialysis
- severe comorbidities not allowing to follow the study protocol
- concomitant participation in another study
- previous participation in this study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Märkische Dialysezentren GmbH
Lüdenscheid, 58509, Germany
Nephrologische Gemeinschaftspraxis
Lüdenscheid, 58509, Germany
Städt. Klinikum Solingen gemeinnützige GmbH Klinik für Nephrologie und Allgemeine Innere Medizin
Solingen, 42653, Germany
PHV Dialysezentrum
Wetzlar, 35578, Germany
Related Publications (1)
Natale P, Ju A, Strippoli GF, Craig JC, Saglimbene VM, Unruh ML, Stallone G, Jaure A. Interventions for fatigue in people with kidney failure requiring dialysis. Cochrane Database Syst Rev. 2023 Aug 31;8(8):CD013074. doi: 10.1002/14651858.CD013074.pub2.
PMID: 37651553DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Schmitz, Dr.
Städt. Klinikum Solingen gemeinnützige GmbH Klinik für Nephrologie und Allgemeine Innere Medizin
- PRINCIPAL INVESTIGATOR
Olaf Loke, Dr.
Nephrologische Gemeinschaftspraxis
- PRINCIPAL INVESTIGATOR
Klaus Kalb, Dr.
Märkische Dialysezentren GmbH
- PRINCIPAL INVESTIGATOR
Bernhard Fach, Dr.
PHV Dialysezentrum
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 20, 2011
First Posted
February 14, 2012
Study Start
October 1, 2011
Primary Completion
April 1, 2013
Study Completion
August 1, 2013
Last Updated
June 6, 2014
Record last verified: 2014-06