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NCT Number: NCT07808944

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

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.

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Key information

Conditions

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

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

SCDU Nefrologia e Dialisi

Alessandria, 15121, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Primary outcomes

  1. Profile of circulating trace element levels

    Time frame: 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 outcomes

  1. Evaluation of the impact of hemodialysis treatment

    Time frame: Baseline and after 6 month

    Evaluation of the impact of hemodialysis treatment on the removal of metals in blood and the dialysis bath

  2. Association between baseline trace elements levels and clinical manifestations.

    Time frame: Baseline and after 6 month

    Statistical evaluation of any association between baseline trace elements levels and clinical manifestations.

  3. Predictor of mortality

    Time frame: Baseline and after 6 month

    Evaluation of Cu/Zn ratio as a predictor of mortality

  4. FACT-Cog questionnaire.

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria

Other

Registry information

Official study title

Trace Element Imbalances in Patients With Chronic Kidney Disease (CKD) Undergoing Dialysis: the Role of Hemodialysis Treatment as an Environmental Factor

Acronym: SQUIL-CKD

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 9, 2026
Registry last updated
Sep 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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