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Prediction of Risk of Hypotension in Hemodialysis

NCT ID: NCT03350308

Last Updated: 2024-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-01

Study Completion Date

2023-12-27

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Chronical Kidney Disease Hypotension Residual Blood Volume Hemodialysis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Patients with chronic end-stage renal failure

hemodialysis

Intervention Type 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

Interventions

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hemodialysis

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fresenius Medical Care North America

INDUSTRY

Sponsor Role collaborator

Centre de dialyse AURA Plaisance

UNKNOWN

Sponsor Role collaborator

Pôle Santé République

OTHER

Sponsor Role collaborator

Service de Néphrologie et Hémodialyse

UNKNOWN

Sponsor Role collaborator

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Julien ANIORT

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

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CHU Clermont-Ferrand

Clermont-Ferrand, , France

Site Status

Countries

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France

Other Identifiers

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2014-A01538-39

Identifier Type: OTHER

Identifier Source: secondary_id

CHU-363

Identifier Type: -

Identifier Source: org_study_id