Chronical Kidney DiseaseIMHOTEPNCT03350308
Prediction of Risk of Hypotension in Hemodialysis
An observational study of Chronical Kidney Disease and Hypotension, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
The main objective is to establish a statistical predictive model of the risk of intradialytic hypotension during hemodialysis (HD) or hemodiafiltration (HDF) sessions based on the measurement of residual blood volume and excess extracellular hydration. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronical Kidney Disease, Hypotension, Residual Blood Volume
- What is being tested?
- hemodialysis
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2015to 27 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Patients with chronic end-stage renal failure
Who may be able to join
- 18 years old minimum patients
- Patients with chronic end-stage renal failure
- Patients treated with hemodialysis for at least 3 months, 3 times a week (duration of sessions 3 to 5 hours)
- Patients with at least 2 episodes of intradialytic hypotension in the last month
- Patients without acute events within 3 months prior to inclusion
- Patients affiliated with or receiving social security benefits
Who cannot join
- Hemoglobin levels outside the limits of measurement (<7 g/L or >15g/L)
- Patients whose probable survival does not exceed 6 months
- Patients with progressive acute pathology
- Patient following another research protocol that may influence results
- Patients with psychiatric pathology or cognitive impairments that make them unable to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
The main objective is to establish a statistical predictive model of the risk of intradialytic hypotension during hemodialysis (HD) or hemodiafiltration (HDF) sessions based on the measurement of residual blood volume and excess extracellular hydration. The secondary objective is to study the impact of dysfunction in the mechanisms of compensation for decreased blood volume (heart disease, neuropathy, drugs) on the risk of intradialytic hypotension.
Read the detailed description
The duration of the study is 4 weeks for each patient. It will first be carried out a spectral analysis of heart rate variability (CHU of Clermont Ferrand only) and a measurement of intracellular and extracellular volumes by bioimpedancemetry. During the next 9 sessions, the decrease in the VSR will be recorded using an optical haematocrit measurement system. Blood pressure and heart rate will be measured every 30 minutes using an automatic blood pressure monitor and whenever the patient's nurse deems it necessary.
- Being tested
- hemodialysis
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hemodialysisOther
The main objective is to establish a statistical predictive model of the risk of intradialytic hypotension during hemodialysis (HD) or hemodiafiltration (HDF) sessions based on the measurement of residual blood volume and excess extracellular hydration
| Study group | Role | What they receive |
|---|---|---|
| Patients with chronic end-stage renal failure | Not described Receives: Other: hemodialysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk of PAS with symptom
The primary outcome will be the risk of a decrease in PAS of more than 20 mmHg or a decrease in WFP of at least 10 mmHg associated with clinical symptomatology (vertigo, malaise, nausea or cramps)
Measured: at 3 week
Secondary outcomes (3)
Risk of PAS with symptom without symptom
The risk of a decrease in PAS of more than 20 mmHg or a decrease in WFP of at least 10 mmHg (with or without symptoms)
Measured: at 3 week
risk of reduction of PAS below 90 mmHg (with or without symptoms)
Measured: at 3 week
risk of isolated symptoms caracterized by vertigo, discomfort, nausea or cramps
Measured: at 3 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2017
- Study start1 Jan 2015
- Primary completion27 Dec 2023
- Study completion27 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronical Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Fresenius Medical Care North America, Centre de dialyse AURA Plaisance, Pôle Santé République, Service de Néphrologie et Hémodialyse
- Responsible party
- Sponsor
- Investigators
- Julien ANIORT, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03350308
- Sponsor's protocol ID
- CHU-363
- Other IDs
- 2014-A01538-39
- Acronym
- IMHOTEP
- Status last verified
- Aug 2026
- First submitted
- 15 Nov 2017
- Last updated
- 7 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Aniort J, Bachelet T, Seris P, Dolley-Hitze T, Bouiller M, Beji C, Batel V, Pereira B, Attaf D, Kopperschmidt P, Heng AE, Canaud B. Continuous monitoring of relative blood volume allows real-time assessment of intradialytic hypotension risk. Clin Kidney J. 2026 Feb 19;19(4):sfag052. doi: 10.1093/ckj/sfag052. eCollection 2026 Apr.
PubMed 42027896
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Risk of Hypotension in Hemodialysis
- ClinicalTrials.gov ID
- NCT03350308
- Acronym / sponsor ID
- IMHOTEP / CHU-363
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Fresenius Medical Care North America, Centre de dialyse AURA Plaisance, Pôle Santé République, Service de Néphrologie et Hémodialyse
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 27 Dec 2023 (actual)
- Study completion
- 27 Dec 2023 (actual)
- First posted
- 22 Nov 2017 (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.
The main objective is to establish a statistical predictive model of the risk of intradialytic hypotension during hemodialysis (HD) or hemodiafiltration (HDF) sessions based on the measurement of residual blood volume and excess extracellular hydration. The secondary objective is to study the impact of dysfunction in the mechanisms of compensation for decreased blood volume (heart disease, neuropathy, drugs) on the risk of intradialytic hypotension.
Detailed description
The duration of the study is 4 weeks for each patient. It will first be carried out a spectral analysis of heart rate variability (CHU of Clermont Ferrand only) and a measurement of intracellular and extracellular volumes by bioimpedancemetry. During the next 9 sessions, the decrease in the VSR will be recorded using an optical haematocrit measurement system. Blood pressure and heart rate will be measured every 30 minutes using an automatic blood pressure monitor and whenever the patient's nurse deems it necessary.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with chronic end-stage renal failure | – | Other: hemodialysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic end-stage renal failure
Key inclusion criteria (6 listed)
- 18 years old minimum patients
- Patients with chronic end-stage renal failure
- Patients treated with hemodialysis for at least 3 months, 3 times a week (duration of sessions 3 to 5 hours)
- Patients with at least 2 episodes of intradialytic hypotension in the last month
- Patients without acute events within 3 months prior to inclusion
Key exclusion criteria (5 listed)
- Hemoglobin levels outside the limits of measurement (<7 g/L or >15g/L)
- Patients whose probable survival does not exceed 6 months
- Patients with progressive acute pathology
- Patient following another research protocol that may influence results
- Patients with psychiatric pathology or cognitive impairments that make them unable to give informed consent
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 |
|---|---|---|
| hemodialysisThe main objective is to establish a statistical predictive model of the risk of intradialytic hypotension during hemodialysis (HD) or hemodiafiltration (HDF) sessions based on the measurement of residual blood volume and excess extracellular hydration | Other | Patients with chronic end-stage renal failure |
Primary outcome
Risk of PAS with symptom
Time frame: at 3 week
The primary outcome will be the risk of a decrease in PAS of more than 20 mmHg or a decrease in WFP of at least 10 mmHg associated with clinical symptomatology (vertigo, malaise, nausea or cramps)
3 secondary outcomes
Risk of PAS with symptom without symptom
Time frame: at 3 week
risk of reduction of PAS below 90 mmHg (with or without symptoms)
Time frame: at 3 week
risk of isolated symptoms caracterized by vertigo, discomfort, nausea or cramps
Time frame: at 3 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Results publication: PubMed 42027896Aniort J, Bachelet T, Seris P, Dolley-Hitze T, Bouiller M, Beji C, Batel V, Pereira B, Attaf D, Kopperschmidt P, Heng AE, Canaud B. Continuous monitoring of relative blood volume allows real-time assessment of intradialytic hypotension risk. Clin Kidney J. 2026 Feb 19;19(4):sfag052. doi: 10.1093/ckj/sfag052. eCollection 2026 Apr.
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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.
Julien ANIORT principal investigator
University Hospital, Clermont-Ferrand
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 Chronical Kidney Disease and Hypotension, run by University Hospital, Clermont-Ferrand 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 6 inclusion and 5 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: finished, as of the sponsor's last update on 7 Aug 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Risk of PAS with symptom (time frame: at 3 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03350308, which also lists 1 linked publication.
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 7 Aug 2026.