Prediction of Risk of Hypotension in Hemodialysis

Hypotension Clinical Trial

— IMHOTEP  

Official title:

Prediction of Risk of Hypotension in Hemodialysis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03350308
• Other study ID #: CHU-363
• Secondary ID: 2014-A01538-39
• Status: Recruiting
• Start date: January 1, 2015
• Est. completion date: December 31, 2019

Study information

• Verified date: February 2019
• Source: University Hospital, Clermont-Ferrand
• Contact: Patrick LACARIN
• Phone: 04 73 75 11 95
• Email: placarin[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2019
• Est. primary completion date: December 3, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronical Kidney Disease
• Hemodialysis
• Hypotension
• Kidney Diseases
• Residual Blood Volume

Intervention

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

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (5)

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

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	risk of reduction of PAS below 90 mmHg (with or without symptoms)		at 3 week
Secondary	risk of isolated symptoms caracterized by vertigo, discomfort, nausea or cramps		at 3 week