Status:
COMPLETED
Prediction of Risk of Hypotension in Hemodialysis
Lead Sponsor:
University Hospital, Clermont-Ferrand
Collaborating Sponsors:
Fresenius Medical Care North America
Centre de dialyse AURA Plaisance
Conditions:
Chronical Kidney Disease
Hypotension
Eligibility:
All Genders
18+ years
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 resi...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2015
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 27 2023
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03350308
Start Date
January 1 2015
End Date
December 27 2023
Last Update
December 12 2024
Active Locations (1)
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1
CHU Clermont-Ferrand
Clermont-Ferrand, France, 63003