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NCT Number: NCT07438925

Copeptin Concentration Measured in Plasma Samples and Intradialytic Blood Pressure Variation

Vasopressin is a key regulator of water and vascular homeostasis, acting through V2 receptors to control renal water reabsorption and through V1a receptors to influence vascular tone. Copeptin, a stable surrogate marker of vasopressin release, provides a reliable measure of vasopressin activity. In hemodialysis, where ultrafiltration and osmotic shifts challenge fluid balance, the contribution of vasopressin to intradialytic blood pressure regulation remains uncertain. Elevated copeptin levels in dialysis patients have been associated with interdialytic weight gain and adverse cardiovascular outcomes. This study (CODIALHYP) tests the hypothesis that vasopressin activity, assessed through copeptin levels, is associated with intradialytic hypertension. The primary objective is to evaluate the relationship between copeptin concentrations and blood pressure changes during hemodialysis. Secondary objectives include assessing whether vasopressin's antidiuretic effect is preserved in hemodialysis patients and exploring the contribution of other hormonal pathways involved in fluid and vascular regulation.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Hemodialysis Diabetes Insipidus Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pituitary Diseases Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHRU de Nancy

Vandœuvre-lès-Nancy, 54500, France

About this study

This study investigates the role of vasopressin activity, assessed through copeptin levels, in the hemodynamic changes occurring during hemodialysis. Vasopressin is involved in both water homeostasis and vascular regulation, yet its contribution to intradialytic blood pressure variations remains insufficiently characterized. Hemodialysis induces rapid shifts in osmotic gradients and extracellular volume, creating conditions in which vasopressinmediated mechanisms may influence vascular tone and fluid balance. The research is based on a retrospective observational design involving chronic hemodialysis patients. Clinical records were reviewed to collect blood pressure measurements obtained before, during, and after dialysis sessions, as well as laboratory data including copeptin, plasma osmolality, cortisol, and aldosterone.

When residual diuresis was present, urinary volume and osmolality were documented. Additional information related to dry weight, ultrafiltration parameters, and routine markers of fluid balance was extracted from standard clinical evaluations.

These data provide a framework for examining the association between vasopressin activity and intradialytic hypertension, and for exploring the contribution of other hormonal pathways involved in fluid and vascular regulation.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patients (≥18 years old).
  • Undergoing chronic hemodialysis treatment > 3 months.
  • Availability of routine predialysis blood samples for copeptin and biochemical measurements.
  • Availability of blood pressure recordings before, during, and after hemodialysis sessions.

No exclusion criteria if inclusion criteria is filled

Treatment and study plan

Routine biology samples et blood pressure mesures

Diagnostic Test

Copeptin concentration will be measured from routine plasma samples, and blood pressure values will be recorded before, during, and after hemodialysis sessions using standard clinical monitoring. The primary outcome is the association between copeptin levels and intradialytic blood pressure variation.

Primary outcomes

  1. Copeptin Concentration Measured in Plasma Samples and Intradialytic Blood Pressure Variation

    Time frame: At baseline (M0) and at 3 months (M3), with copeptin measured at dialysis initiation (prehemodialysis) without additional blood sampling.

    Copeptin concentration will be measured from routine plasma samples, and blood pressure values will be recorded before, during, and after hemodialysis sessions using standard clinical monitoring. The primary outcome is the correlation between copeptin levels and intradialytic blood pressure variation.

Secondary outcomes

  1. Plasma Osmolality

    Time frame: Baseline (M0)

    Plasma osmolality (mOsm/kg) will be obtained from routine predialysis laboratory measurements. These measurements will be used to evaluate whether the antidiuretic effect of vasopressin is preserved in hemodialysis patients.

  2. Copeptin level

    Time frame: Baseline (M0)

    Copeptin levels (pmol/L) will be obtained from routine predialysis laboratory measurements.

  3. Serum Cortisol and Aldosterone Concentrations

    Time frame: Baseline (M0)

    Serum cortisol and aldosterone concentrations will be measured from routine predialysis blood samples collected as part of standard care. These hormonal markers will be used to explore additional mechanisms potentially involved in intradialytic hypertension.

  4. Urinary Osmolality

    Time frame: Baseline (M0)

    Urinary volume and urine osmolality will be collected from standard clinical assessments in patients with residual diuresis. These measurements will be used to evaluate whether the antidiuretic effect of vasopressin is preserved in hemodialysis patients.

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Collaborators

  • ALTIR Nancy

Registry information

Acronym: CODIALHYP

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 27, 2026
Registry last updated
Feb 27, 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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