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OpenTrials
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NCT Number: NCT07465042

Symptom Clusters in Hemodialysis : Insights From a Multicenter Analysis Using Tetrachoric Correlations

In 2025, Guerraoui et al. published the Concordance Study in Clinical Kidney Journal, a large multicenter cross-sectional study embedded within the French REIN registry. This study compared symptoms reported by hemodialysis patients using the Dialysis Symptom Index (DSI) with clinician-perceived symptoms, revealing a high symptom burden and marked patient-clinician discordance [3].

The present work is a secondary analysis of the Concordance Study dataset. Building on the original findings, this analysis aims to deepen understanding of symptom organization and determinants in hemodialysis using multivariate and correlation-based approaches. Specifically, our objectives were :

1. to identify and characterize symptom clusters using tetrachoric correlations and hierarchical clustering; 2. to examine associations between symptoms (and clusters) and comorbidity burden, while assessing potential sex-specific patterns in symptom expression.

Through this secondary analysis, we aim to clarify the internal architecture of symptom co-occurrence, identify key demographic drivers such as sex, and generate evidence supporting cluster-informed, individualized approaches to symptom assessment and management in routine nephrology care.

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Key information

Conditions

DIALYSIS SYMPTOMS AND ANXIETY Hemodialysis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CH Saint Joseph Saint Luc, Lyon, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • undergoing maintenance hemodialysis
  • ≥18 years
  • dialysis vintage ≥3 months

Exclusion criteria

  • patients with cognitive impairment (which was assessed with the presence of either clinical judgement or formal diagnosis)
  • patients who did not have the ability to express consent or refused to participant in the study
  • patients who could not read or understand French well enough to complete the questionnaire.

Treatment and study plan

observational cross sectional study

Other

no intervention : observational

Primary outcomes

  1. identify and characterize symptom clusters

    Time frame: one day enrollment

    identify and characterize symptom clusters using tetrachoric correlations and hierarchical clustering

  2. examine associations between symptoms (and clusters) and comorbidity burden

    Time frame: one day enrollment

    examine associations between symptoms (and clusters) and comorbidity burden, while assessing potential sex-specific patterns in symptom expression

Sponsors and collaborators

Lead sponsor

Calydial

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Mar 11, 2026
Registry last updated
Mar 11, 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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