Chronic Kidney Disease (CKD)
Conditions
Brief summary
Chronic kidney disease (CKD) is associated with alterations in the balance of trace elements and metals, which may result from reduced dietary intake, impaired renal function, dialysis-related removal, or environmental exposure. Hemodialysis may play a relevant role in both the removal and potential introduction of these elements. This pilot study aims to investigate trace element and metal imbalances in older patients with advanced CKD and to assess the influence of bicarbonate hemodialysis and dialysis-related environmental exposure on their elemental profile.
Detailed description
This is a prospective, observational, monocentric pilot study involving patients aged 60 years or older with advanced chronic kidney disease (CKD). Participants will be divided into two groups: patients about to start bicarbonate hemodialysis (BIC-HD) and patients undergoing BIC-HD for at least 5 years, with at least 10 patients per group. The study aims to assess blood levels of selected trace elements and metals, including zinc, copper, manganese, lead, aluminum, mercury, selenium, cadmium and chromium, before and after hemodialysis, and to investigate the potential influence of dialysis treatment and dialysis-related environmental exposure. Blood and dialysate samples will be collected before and after dialysis, together with samples of the tap water used for the treatment. Samples will be analyzed using inductively coupled plasma mass spectrometry (ICP-MS) and inductively coupled plasma optical emission spectrometry (ICP-OES). Clinical and laboratory data will also be collected to investigate the association between elemental imbalances and selected clinical manifestations, including cardiovascular and infectious events, anemia, peripheral neuropathy, cognitive impairment and malnutrition. Cognitive function will be assessed at baseline and after 6 months using the FACT-Cog questionnaire. Participants will be followed for 6 months. The study has an overall duration of 12 months, including enrollment, follow-up, sample analysis and statistical evaluation.
Interventions
OTHERCompare blood concentrations of selected trace elements and metals before and after hemodialysis
The main objective is to compare blood concentrations of selected trace elements and metals before and after hemodialysis in incident and prevalent patients. The elements investigated will include zinc, copper, manganese, lead, aluminum, mercury, selenium, cadmium and chromium. The study will also investigate whether the elemental profile differs according to the duration of exposure to hemodialysis.
Sponsors
Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients aged 60 years or older; * Patients attending the Nephrology and Dialysis Unit (SCDU) of AOU AL; * Patients about to start hemodialysis (HD) using the bicarbonate dialysis (BIC-HD) technique (Group A patients) or patients already on dialysis for at least 5 years using the bicarbonate dialysis (BIC-HD) technique (Group B patients); * Patients with stage V or Vd chronic kidney disease (CKD); * Signature of informed consent.
Exclusion criteria
* Patients with previous kidney transplants (resumption of dialysis treatment after the transplant period).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Profile of circulating trace element levels | Baseline, pre and post treatment and after 6 months | Comparison of blood levels of trace elements regarding deficiency and excess in the incident and prevalent patients groups, before and after dialysis treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the impact of hemodialysis treatment | Baseline and after 6 month | Evaluation of the impact of hemodialysis treatment on the removal of metals in blood and the dialysis bath |
| Association between baseline trace elements levels and clinical manifestations. | Baseline and after 6 month | Statistical evaluation of any association between baseline trace elements levels and clinical manifestations. |
| Predictor of mortality | Baseline and after 6 month | Evaluation of Cu/Zn ratio as a predictor of mortality |
| FACT-Cog questionnaire. | Baseline and after 6 month | Assessment of cognitive function through FACT-Cog questionnaire, a 5-point Likert scale (ranging from 0 to 4 per item). |
Countries
Italy
Outcome results
None listed