Application of Citrate Dialysate in Chronic Haemodialysis

Study Overview
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Brief Summary
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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.

Detailed Description
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It is hypothesized that citrate dialysate may provide a local anticoagulation effect in the dialyser improving removal of uremic toxins. 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.

Official Title
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Application of Citrate Dialysate in Chronic Haemodialysis

Conditions
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Chronic Renal Disease

Intervention / Treatment
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* Device: Citrate dialysate (CiDi)
* Device: Standard dialysate (StDi)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: HD treated with standard dialysate<br> | Device: Standard dialysate (StDi)<br>* Use during chronic dialysis 3x/week<br>|
| Active Comparator: post-dilution oHDF with standard dialysate<br> | Device: Standard dialysate (StDi)<br>* Use during chronic dialysis 3x/week<br>|
| Experimental: pre-dilution oHDF with citrate dialysate<br> | Device: Citrate dialysate (CiDi)<br>* Use during chronic dialysis 3x/week<br>|
| Experimental: HD treated with citrate dialysate<br> | Device: Citrate dialysate (CiDi)<br>* Use during chronic dialysis 3x/week<br>|
| Experimental: post-dilution oHDF with citrate dialysate<br> | Device: Citrate dialysate (CiDi)<br>* Use during chronic dialysis 3x/week<br>|
| Active Comparator: pre-dilution oHDF with standard dialysate<br> | Device: Standard dialysate (StDi)<br>* Use during chronic dialysis 3x/week<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of clinically relevant acid-base disturbances | post-dialysis bicarbonate concentration ≥ 32 mmol/l | patients are followed for 8 weeks | 
| Occurrence of clinically relevant acid-base disturbances | pre-treatment bicarbonate concentration ≥ 27 mmol/l | patients are followed for 8 weeks | 
| Occurrence of clinically relevant intradialytic complications (adverse events) | related to citrate dialysate | patients are followed for 8 weeks | 
| Occurrence of clinically relevant adverse events | related to citrate | patients are followed for 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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citrate dialysate, dialysis, calcium