HemodialysisCODIALHYPNCT07438925
Copeptin Concentration Measured in Plasma Samples and Intradialytic Blood Pressure Variation
An observational study of Hemodialysis, run by Central Hospital, Nancy, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodialysis
- What is being tested?
- Routine biology samples et blood pressure mesures
- How many people
- 71 participants
- Where
- 1 siteFrance
- Study dates
- 22 Dec 2025to 1 Mar 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Conditions
- Hemodialysis
- Being tested
- Routine biology samples et blood pressure mesures
- Keywords
- Intradialytic Hypertension, CTAVP, Fluid Balance, Vasopressin, Hemodialysis, Copeption
- Medical subject headings
- Diabetes Insipidus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine biology samples et blood pressure mesuresDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Routine biology samples et blood pressure mesures |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline (M0) and at 3 months (M3), with copeptin measured at dialysis initiation (prehemodialysis) without additional blood sampling.
Secondary outcomes (4)
Plasma Osmolality
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.
Measured: Baseline (M0)
Copeptin level
Copeptin levels (pmol/L) will be obtained from routine predialysis laboratory measurements.
Measured: Baseline (M0)
Serum Cortisol and Aldosterone Concentrations
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.
Measured: Baseline (M0)
Urinary Osmolality
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.
Measured: Baseline (M0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start22 Dec 2025
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemodialysisStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Collaborators
- ALTIR Nancy
- Responsible party
- Principal investigator, PETERS Nicolas, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07438925
- Sponsor's protocol ID
- 2025PI192-671
- Acronym
- CODIALHYP
- Status last verified
- Feb 2026
- First submitted
- 11 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The investigators designed the study as a pilot study and do not intend to share IPD with other study
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Copeptin Concentration Measured in Plasma Samples and Intradialytic Blood Pressure Variation
- ClinicalTrials.gov ID
- NCT07438925
- Acronym / sponsor ID
- CODIALHYP / 2025PI192-671
- Conditions
- Hemodialysis
- Keywords
- Intradialytic Hypertension, CTAVP, Fluid Balance, Vasopressin, Hemodialysis, Copeption
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Collaborators
- ALTIR Nancy
- Study start
- 22 Dec 2025 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Selected hemodialysis patients group | – | Diagnostic Test: Routine biology samples et blood pressure mesuresThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Routine biology samples et blood pressure mesuresCopeptin 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. | Diagnostic test | Selected hemodialysis patients group |
Primary outcome
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.
4 secondary outcomes
Plasma Osmolality
Time frame: Baseline (M0)
Copeptin level
Time frame: Baseline (M0)
Serum Cortisol and Aldosterone Concentrations
Time frame: Baseline (M0)
Urinary Osmolality
Time frame: Baseline (M0)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: Undecided. The investigators designed the study as a pilot study and do not intend to share IPD with other study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemodialysis, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.