Chronical Kidney Disease, Hemodialysis, Hypotension, Residual Blood Volume
Conditions
Brief 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. 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.
Interventions
OTHERhemodialysis
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
Sponsors
University Hospital, Clermont-Ferrand
Fresenius Medical Care North America
Centre de dialyse AURA Plaisance
Pôle Santé République
Service de Néphrologie et Hémodialyse
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Risk of PAS with symptom | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Risk of PAS with symptom without symptom | 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) |
| risk of reduction of PAS below 90 mmHg (with or without symptoms) | at 3 week | — |
| risk of isolated symptoms caracterized by vertigo, discomfort, nausea or cramps | at 3 week | — |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORJulien ANIORT
University Hospital, Clermont-Ferrand
Outcome results
None listed