Clinical trial NCT03350308: Prediction of Risk of Hypotension in Hemodialysis
Official title: Prediction of Risk of Hypotension in Hemodialysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronical Kidney Disease
Hypotension
Residual Blood Volume
Hemodialysis
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: Fresenius Medical Care North America
name: Centre de dialyse AURA Plaisance
name: Pôle Santé République
name: Service de Néphrologie et Hémodialyse
First posted: 2017-11-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic end-stage renal failure

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.

Eligibility criteria: 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

Primary outcomes:
measure: Risk of PAS with symptom
timeFrame: at 3 week
Secondary outcomes:
measure: Risk of PAS with symptom without symptom
timeFrame: at 3 week
measure: risk of reduction of PAS below 90 mmHg (with or without symptoms)
timeFrame: at 3 week
measure: risk of isolated symptoms caracterized by vertigo, discomfort, nausea or cramps
timeFrame: at 3 week
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Julien ANIORT
role: PRINCIPAL_INVESTIGATOR
References: