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This pilot study aims to evaluate in an exploratory way the predictive power of a novel in vitro test (T50 Calcification Inhibition Test, T50 CIT), which measures the mineralization inhibition capacity of blood, in terms of its association with time to all-cause mortality in haemodialysis patients.
Disturbances in mineral and bone metabolism centrally contribute to the exceedingly elevated risk for cardiovascular (CV) disease in dialysis patients. A novel in vitro test (T50 Calcification Inhibition Test, T50 CIT) has been developed, which measures the mineralization inhibition capacity of blood. This pilot study aims to exploratory examine the predictive power of baseline T50 CIT and fetuin-A (protein which is centrally involved in the inhibition of the formation of crystalline hydroxyapatite) values in terms of their association with all-cause mortality in an unselected cohort of haemodialysis patients. Moreover, the study shall investigate the association between baseline T50 CIT and fetuin-A values with CV related mortality, all-cause hospitalization and CV related hospitalization. Finally, the study aims to compare the predictive power of T50 CIT values with a set of six established calcification-related parameters (albumin, phosphate, calcium, magnesium, bicarbonate and fetuin-A). After baseline blood sampling the patients will be followed for 2 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| T50 Calcification Inhibition Test (CIT) | Other | Measurement of T50 CIT and fetuin-A serum values |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| T50 Calcification Inhibition Test (CIT) | Diagnostic Test | Measurement of predialysis T50 CIT and fetuin-A values in serum of hemodialysis patients |
|
| Measure | Description | Time Frame |
|---|---|---|
| T50 CIT values | The primary objective of this pilot study is to exploratory examine the predictive power of baseline T50 CIT values in terms of their association with time to all-cause mortality in haemodialysis patients. | Baseline after signed informed consent |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Abraham Rincon Bello, Dr. | Fresenius Medical Care Spain | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro de Diálisis Barcelona - Glories | Barcelona | 08013 | Spain | |||
| Centro de Diálisis Barcelona - Diagonal |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36792998 | Derived | Zawada AM, Wolf M, Rincon Bello A, Ramos-Sanchez R, Hurtado Munoz S, Ribera Tello L, Mora-Macia J, Fernandez-Robres MA, Soler-Garcia J, Aguilera Jover J, Moreso F, Stuard S, Stauss-Grabo M, Winter A, Canaud B. Assessment of a serum calcification propensity test for the prediction of all-cause mortality among hemodialysis patients. BMC Nephrol. 2023 Feb 15;24(1):35. doi: 10.1186/s12882-023-03069-6. |
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| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D002318 | Cardiovascular Diseases |
| D061205 | Vascular Calcification |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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Exploratory, interventional, open, multi-center, prospective
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| Barcelona |
| 08019 |
| Spain |
| Centro de Diálisis Barcelona - Rosselló | Barcelona | 08029 | Spain |
| Centro de Diálisis Granollers | Granollers | 08401 | Spain |
| Centro de Diálisis Hospitalet | L'Hospitalet de Llobregat | 08901 | Spain |
| Centro de Diálisis Reus | Reus | 43205 | Spain |
| Centro de Diálisis Tarragona | Tarragona | 43007 | Spain |
| Centro de Diálisis Terrassa | Terrassa | 08223 | Spain |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002114 | Calcinosis |
| D002128 | Calcium Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |