Prediction of Risk of Hypotension in Hemodialysis (IMHOTEP)
August 5, 2026 updated by: University Hospital, Clermont-Ferrand
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.
Study Overview
Status
Completed
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Clermont-Ferrand, France, 63003
- CHU clermont-ferrand
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients with chronic end-stage renal failure
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patients with chronic end-stage renal failure
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
at 3 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Risk of PAS with symptom without symptom
Time Frame: at 3 week
|
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)
|
at 3 week
|
|
risk of reduction of PAS below 90 mmHg (with or without symptoms)
Time Frame: at 3 week
|
at 3 week
|
|
|
risk of isolated symptoms caracterized by vertigo, discomfort, nausea or cramps
Time Frame: at 3 week
|
at 3 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Julien ANIORT, University Hospital, Clermont-Ferrand
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2015
Primary Completion (Actual)
December 27, 2023
Study Completion (Actual)
December 27, 2023
Study Registration Dates
First Submitted
November 15, 2017
First Submitted That Met QC Criteria
November 17, 2017
First Posted (Actual)
November 22, 2017
Study Record Updates
Last Update Posted (Actual)
August 7, 2026
Last Update Submitted That Met QC Criteria
August 5, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHU-363
- 2014-A01538-39 (Other Identifier: 2014-A01538-39-+)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.