Copeptin Concentration Measured in Plasma Samples and Intradialytic Blood Pressure Variation

NCT07438925 | Active Not Recruiting

• 1 other identifier: 2025PI192-671
• Study Type: observational
• Target: 71
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hemodialysis

Keywords

Intradialytic Hypertension; CTAVP; Fluid Balance; Vasopressin; Hemodialysis; Copeption

Outcome Measures

Primary Outcomes (1)

• Copeptin Concentration Measured in Plasma Samples and Intradialytic Blood Pressure Variation

  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.

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

Secondary Outcomes (4)

• Plasma Osmolality

  Baseline (M0)

• Copeptin level

  Baseline (M0)

• Serum Cortisol and Aldosterone Concentrations

  Baseline (M0)

• Urinary Osmolality

  Baseline (M0)

Study Arms (1)

Selected hemodialysis patients group

The study population consists of adult patients (≥18 years old) undergoing chronic hemodialysis for more than three months. All included patients were clinically stable, not hospitalized at the time of data collection, and received treatment within the ALTIR network (Association Lorraine pour le Traitement de l'Insuffisance Rénale). Data were obtained from three hemodialysis centers: Nancy-Brabois, Champelle, and Épinal.

Diagnostic Test: Routine biology samples et blood pressure mesures

Interventions

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.

Selected hemodialysis patients group

Eligibility Criteria

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

Study Population

The study population consists of adult patients (≥18 years old) undergoing chronic hemodialysis for more than three months. All included patients were clinically stable, not hospitalized at the time of data collection, and received treatment within the ALTIR network (Association Lorraine pour le Traitement de l'Insuffisance Rénale). Data were obtained from three hemodialysis centers: Nancy-Brabois, Champelle, and Épinal.

You may qualify if:

• 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.

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead
• ALTIR Nancy: collaborator

Study Sites (1)

CHRU de Nancy

Vandœuvre-lès-Nancy, 54500, France

Location

MeSH Terms

Conditions

Diabetes Insipidus

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pituitary Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: February 11, 2026
• First Posted: February 27, 2026
• Study Start: December 22, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

FR (1)