Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Prediction of Risk of Hypotension in Hemodialysis (IMHOTEP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03350308
Recruitment Status : Unknown
Verified February 2019 by University Hospital, Clermont-Ferrand.
Recruitment status was:  Recruiting
First Posted : November 22, 2017
Last Update Posted : February 4, 2019
Sponsor:
Collaborators:
Fresenius Medical Care North America
Centre de dialyse AURA Plaisance
Pôle Santé République
Service de Néphrologie et Hémodialyse
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment
Chronical Kidney Disease Hypotension Residual Blood Volume Hemodialysis 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 Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Prediction of Risk of Hypotension in Hemodialysis
Actual Study Start Date : January 1, 2015
Estimated Primary Completion Date : December 3, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with chronic end-stage renal failure
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03350308


Contacts
Layout table for location contacts
Contact: Patrick LACARIN 04 73 75 11 95 placarin@chu-clermontferrand.fr

Locations
Layout table for location information
France
CHU Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63003
Contact: Patrick LACARIN    0473751195    placarin@chu-clermontferrand.fr   
Principal Investigator: Julien ANIORT         
Sub-Investigator: Caroline CREPUT         
Sub-Investigator: Marc BOUILLER         
Sub-Investigator: Myriam ISNARD         
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Fresenius Medical Care North America
Centre de dialyse AURA Plaisance
Pôle Santé République
Service de Néphrologie et Hémodialyse
Investigators
Layout table for investigator information
Principal Investigator: Julien ANIORT University Hospital, Clermont-Ferrand
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT03350308    
Other Study ID Numbers: CHU-363
2014-A01538-39 ( Other Identifier: 2014-A01538-39-+ )
First Posted: November 22, 2017    Key Record Dates
Last Update Posted: February 4, 2019
Last Verified: February 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Kidney Diseases
Hypotension
Urologic Diseases
Vascular Diseases
Cardiovascular Diseases