Chronic Kidney Disease Clinical Trial
— PAROHEMOfficial title:
Periodontal Disease, Inflammation, Nutritional Status And Anaemia Response To Erythropoietin In Chronic Haemodialyzed Patients - The Impact Of Treatment For Periodontal Disease
NCT number | NCT01785355 |
Other study ID # | 005 |
Secondary ID | 00022 |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | September 2012 |
Est. completion date | June 2022 |
Several studies revealed a direct relationship between the severity of periodontal inflammation and CRP (NHANES III, Dumitriu HT et al, 1998). In patients without any other source of inflammation but PDD, proper dental treatment of the disease decreased CRP to normal levels (Dumitriu H.T. et al., 1998; D'Aiuto F. et al, 2004; Borawski J. et al., 2007) Moreover, a direct link between high levels of CRP and atherosclerotic complications has been found in studies conducted both in general population (Ridker PM, et al., 1998; Koenig W, et al., 1999) and in HD subjects (Westhuyzen J, et al., 2000; Iseki K., et al., 1999; Zimmermann J, et al. 1998).
Status | Recruiting |
Enrollment | 30 |
Est. completion date | June 2022 |
Est. primary completion date | September 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility |
Inclusion Criteria: - Hemodialyzed patients with periodontal disease Exclusion Criteria: - Malignancies, Diabetes - Patient refusal to participate |
Country | Name | City | State |
---|---|---|---|
Romania | CMI "Dr Slusanschi Oana" | Bucharest |
Lead Sponsor | Collaborator |
---|---|
Anemia Working Group Romania |
Romania,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Modification of periodontal disease index | Modification of periodontal disease index assessed by the CAL, PPD, bleeding index | 3 months | |
Other | Modification of the quality of life, as assessed by SF-36 and OHIP-14 | Modification of the quality of life, as assessed by SF-36 and OHIP-14 | 6 months | |
Other | Modification of anaemia response to epoetin | Modification of anaemia response to epoetin, as assessed by the ERI and by the cumulative ESAs dose | 6 months | |
Primary | Modification of nutritional status | SGA, whole body bioimpedance, biochemical parameters (serum albumin, predialysis serum urea, serum creatinine, serum phosphates) | 6 months | |
Secondary | Modification of inflammatory status | C Reactive Protein | 6 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
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