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| ID | Type | Description | Link |
|---|---|---|---|
| There is no secondary ID |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HD treated with standard dialysate | Active Comparator |
| |
| post-dilution oHDF with standard dialysate | Active Comparator |
| |
| pre-dilution oHDF with citrate dialysate | Experimental |
| |
| HD treated with citrate dialysate | Experimental |
| |
| post-dilution oHDF with citrate dialysate | Experimental |
| |
| pre-dilution oHDF with standard dialysate | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Citrate dialysate (CiDi) | Device | Use during chronic dialysis 3x/week |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Märkische Dialysezentren GmbH | Lüdenscheid | 58509 | Germany | |||
| Nephrologische Gemeinschaftspraxis |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37651553 | Derived | 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. |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| Standard dialysate (StDi) | Device | Use during chronic dialysis 3x/week |
|
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 |
| Lüdenscheid |
| 58509 |
| Germany |
| Städt. Klinikum Solingen gemeinnützige GmbH Klinik für Nephrologie und Allgemeine Innere Medizin | Solingen | 42653 | Germany |
| PHV Dialysezentrum | Wetzlar | 35578 | Germany |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |