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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-A01538-39 | Other Identifier | 2014-A01538-39-+ |
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| Name | Class |
|---|---|
| Fresenius Medical Care North America | INDUSTRY |
| Centre de dialyse AURA Plaisance | UNKNOWN |
| Pôle Santé République | OTHER |
| Service de Néphrologie et Hémodialyse |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with chronic end-stage renal failure |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hemodialysis | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | at 3 week |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | at 3 week |
| risk of reduction of PAS below 90 mmHg (with or without symptoms) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with chronic end-stage renal failure
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| Name | Affiliation | Role |
|---|---|---|
| Julien ANIORT | University Hospital, Clermont-Ferrand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Clermont-Ferrand | Clermont-Ferrand | 63003 | France |
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| ID | Term |
|---|---|
| D007022 | Hypotension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D006435 | Renal Dialysis |
| ID | Term |
|---|---|
| D017582 | Renal Replacement Therapy |
| D013812 | Therapeutics |
| D016060 | Sorption Detoxification |
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| UNKNOWN |
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| at 3 week |
| risk of isolated symptoms caracterized by vertigo, discomfort, nausea or cramps | at 3 week |