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OpenTrials
Completed

NCT Number: NCT03350308

Prediction of Risk of Hypotension in 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. 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Risk of PAS with symptom

    Time frame: at 3 week

    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)

Secondary outcomes

  1. Risk of PAS with symptom without symptom

    Time frame: at 3 week

    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)

  2. risk of reduction of PAS below 90 mmHg (with or without symptoms)

    Time frame: at 3 week

  3. risk of isolated symptoms caracterized by vertigo, discomfort, nausea or cramps

    Time frame: at 3 week

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Collaborators

  • Centre de dialyse AURA Plaisance
  • Fresenius Medical Care North America
  • Pôle Santé République
  • Service de Néphrologie et Hémodialyse

Registry information

Acronym: IMHOTEP

Important dates

Study start
2015
Primary completion
2023
Study completion
2023
First posted
Nov 22, 2017
Registry last updated
Dec 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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