Prediction of Risk of Hypotension in Hemodialysis (IMHOTEP)

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.

Study Overview

• Status: Unknown
• Conditions: Hemodialysis; Hypotension; Chronical Kidney Disease; Residual Blood Volume
• Intervention / Treatment: Other: hemodialysis

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.

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63003
    • Recruiting
    • CHU Clermont-Ferrand
    • Principal Investigator: Julien ANIORT
    • Sub-Investigator: Caroline CREPUT
    • Sub-Investigator: Marc BOUILLER
    • Sub-Investigator: Myriam ISNARD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with chronic end-stage renal failure

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with chronic end-stage renal failure	Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)		at 3 week
risk of isolated symptoms caracterized by vertigo, discomfort, nausea or cramps		at 3 week

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Collaborators: Fresenius Medical Care North America; Centre de dialyse AURA Plaisance; Pôle Santé République; Service de Néphrologie et Hémodialyse

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Anticipated): December 3, 2019
• Study Completion (Anticipated): December 31, 2019

Study Registration Dates

• First Submitted: November 15, 2017
• First Submitted That Met QC Criteria: November 17, 2017
• First Posted (Actual): November 22, 2017

Study Record Updates

• Last Update Posted (Actual): February 4, 2019
• Last Update Submitted That Met QC Criteria: February 1, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Urologic Diseases; Kidney Diseases; Hypotension
• Other Study ID Numbers: CHU-363; 2014-A01538-39 (Other Identifier: 2014-A01538-39-+)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No