Trace Element Imbalances in Dialysis Patients With CKD: the Role of Hemodialysis

NCT07808944 | Completed

• 1 other identifier: ASO.Nefro.24.03
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Disease (CKD)

Outcome Measures

Primary Outcomes (1)

• Profile of circulating trace element levels

  Comparison of blood levels of trace elements regarding deficiency and excess in the incident and prevalent patients groups, before and after dialysis treatment

  Baseline, pre and post treatment and after 6 months

Secondary Outcomes (4)

• Evaluation of the impact of hemodialysis treatment

  Baseline and after 6 month

• Association between baseline trace elements levels and clinical manifestations.

  Baseline and after 6 month

• Predictor of mortality

  Baseline and after 6 month

• FACT-Cog questionnaire.

  Baseline and after 6 month

Study Arms (2)

Incident patients

Patients with stage V/Vd CKD who are about to start bicarbonate hemodialysis (BIC-HD). 10 patients will be enrolled in this group.

Other: Compare blood concentrations of selected trace elements and metals before and after hemodialysis

Prevalent patients

Patients who have been receiving BIC-HD for at least 5 years. 10 patients will be enrolled in this group.

Other: Compare blood concentrations of selected trace elements and metals before and after hemodialysis

Interventions

Compare blood concentrations of selected trace elements and metals before and after hemodialysis OTHER

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.

Incident patients; Prevalent patients

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with stage IV and Vd chronic kidney disease (CKD)-both those about to start dialysis (incident patients) and those who have been on dialysis for at least 5 years (prevalent patients)

You may qualify if:

• 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.

You may not qualify if:

• Patients with previous kidney transplants (resumption of dialysis treatment after the transplant period).

Sponsors & Collaborators

• Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria: lead

Study Sites (1)

SCDU Nefrologia e Dialisi

Alessandria, Alessandria, 15121, Italy

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2026
• First Posted: September 9, 2026
• Study Start: March 31, 2025
• Primary Completion: February 28, 2026
• Study Completion: March 31, 2026
• Last Updated: September 9, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)