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出境医 / 临床实验 / Study of Abnormalities of the Nervous System in the Occurrence of Intradialytic Arterial Hypotension (SUDHEMO)

Study of Abnormalities of the Nervous System in the Occurrence of Intradialytic Arterial Hypotension (SUDHEMO)

Study Description
Brief Summary:

Intradialytic hypotension is a common complication of hemodialysis sessions in patients with chronic renal failure, with an estimated prevalence of 10 to 30%. This hypotensopn is classically defined by a decrease in systolic blood pressure greater than 30 mmHg associated with clinical signs (cramps, abdominal pain, unconsciousness, convulsions). Its repetition is correlated with cardiovascular events, neurological events and excess mortality. Several clinical factors have been proposed to predict the risk of intradialytic hypotension such as age, certain comorbidities (diabetes, ischemic heart disease...), dialysis modalities (hemodialysis), ultrafiltration, conductivity but also alterations of the autonomic nervous system (especially the sympathetic system).

In recent years, the study of vegetative functions has been facilitated by the use of SUDOSCAN® (Impeto, Paris, France) which is a simple, non-invasive tool that allows the study of Chlorine conductance directly reflecting the activity of small non-myelinated C fibers that innervate the sweat glands. SUDOSCAN® has shown good sensitivity and specificity in the diagnosis of vegetative damage in diabetic patients and also a good correlation with cardiac autonomic neuropathy. More recently, SUDOSCAN® has shown good sensitivity in the detection of neuropathies small fibers especially in diabetic patients. This sensitivity is comparable to QST-type quantitative tests and the correlation with cardiovascular dysautonomia tests is good. This test, simple and fast realization, does not require the active participation of the patient. There is a good correlation between the results of SUDOSCAN® and the reduction of intra-dermal fiber density at cutaneous biopsy.

Hemodialysis patients are at risk of peripheral neurological involvement not only because of an increasing incidence of diabetes (30-40%) but also because of the abnormal production and elimination of certain uremic toxins. Few studies exist on the anomalies of the vegetative system in hemodialysis. A recent publication has suggested a difference in nerve excitability depending on the type of hemodialysis suggesting nerve changes secondary to ionic changes. The identification of patients at risk of intradialytic hypotension during dialysis sessions could be useful for adapting hemodialysis protocols.

Patients will be classified into 2 groups according to the occurrence of intradialytic hypotension. Group 1 corresponds to patients with intradialytic hypotension and group 2 corresponds to patients without intradialytic hypotension.


Condition or disease Intervention/treatment Phase
Hemodialysis Complication Diagnostic Test: Cutaneous conductance to chlorine by SUDOSCAN Not Applicable

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 176 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients will be classified into 2 groups according to the occurrence of intradialytic hypotension which is defined as a decrease in systolic blood pressure greater than 30 mmHg associated with clinical signs (cramps, abdominal pain, unconsciousness, convulsions). Group 1 corresponds to patients with intradialytic hypotension and group 2 corresponds to patients without intradialytic hypotension. This study aims to measure the cutaneous conductance to chlorine by SUDOSCAN® in all dialysis patients and to seek a link between the results of this examination and the occurrence of discomfort during hemodialysis sessions.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Study of Abnormalities of the Vegetative Nervous System in the Occurrence of Intradialytic Arterial Hypotension
Actual Study Start Date : June 25, 2019
Actual Primary Completion Date : May 31, 2020
Actual Study Completion Date : May 11, 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: Group 1: patients without intradialytic hypotension
The investigators will measure the cutaneous conductance to chlorine by SUDOSCAN® in all dialysis patients without intradialytic hypotension and to seek a link between the results of this examination and the occurrence of discomfort during hemodialysis sessions.
Diagnostic Test: Cutaneous conductance to chlorine by SUDOSCAN
The additional examination, related to this research protocol, corresponds to a record of cutaneous conductance with chlorine. This recording of 2 min 30 is done thanks to SUDOSCAN® within 30 minutes before the dialysis session (before the "connection" to the dialysis machine) and within 30 minutes after the end of the dialysis with a measurement of the tension blood pressure and heart rate immediately before SUDOSCAN®.

Experimental: Group 2: patients with intradialytic hypotension
The investigators will measure the cutaneous conductance to chlorine by SUDOSCAN® in all dialysis patients with intradialytic hypotension and to seek a link between the results of this examination and the occurrence of discomfort during hemodialysis sessions.
Diagnostic Test: Cutaneous conductance to chlorine by SUDOSCAN
The additional examination, related to this research protocol, corresponds to a record of cutaneous conductance with chlorine. This recording of 2 min 30 is done thanks to SUDOSCAN® within 30 minutes before the dialysis session (before the "connection" to the dialysis machine) and within 30 minutes after the end of the dialysis with a measurement of the tension blood pressure and heart rate immediately before SUDOSCAN®.

Outcome Measures
Primary Outcome Measures :
  1. Cutaneous conductance to chlorine by SUDOSCAN before hemiodialysis [ Time Frame: Day 1 ]
    This outcome is to measure cutaneous conductance to chlorine by SUDOSCAN, 30 minuts before hemodialysis.


Secondary Outcome Measures :
  1. Cutaneous conductance to chlorine by SUDOSCAN after hemiodialysis [ Time Frame: Day 1 ]
    This outcome is to measure cutaneous conductance to chlorine by SUDOSCAN, 30 minuts after hemodialysis.


Eligibility Criteria
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
Criteria

Inclusion Criteria:

  • Patient whose age ≥ 18 years
  • Patient on hemodialysis for more than 6 months
  • Patient affiliated with a health insurance plan
  • Francophone patient
  • Patient giving free, informed and express consent

Exclusion Criteria:

  • Patient with lesions, wounds, amputations preventing the measurement of the chlorine conductance of the palms of the hands and feet
  • Patient with a disability that prevents them from standing while measuring conductance / SUDOSCAN®
  • Patient already included in an interventional research protocol
  • Patient under tutorship or curatorship
  • Patient deprived of liberty
Contacts and Locations

Locations
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France
AURA Paris Plaisance
Paris, France, 75014
Sponsors and Collaborators
Groupe Hospitalier Paris Saint Joseph
Investigators
Layout table for investigator information
Principal Investigator: Pauline REACH, MD Groupe Hospitalier Paris Saint Joseph
Tracking Information
First Submitted Date  ICMJE June 17, 2019
First Posted Date  ICMJE June 18, 2019
Last Update Posted Date June 2, 2021
Actual Study Start Date  ICMJE June 25, 2019
Actual Primary Completion Date May 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 17, 2019)
Cutaneous conductance to chlorine by SUDOSCAN before hemiodialysis [ Time Frame: Day 1 ]
This outcome is to measure cutaneous conductance to chlorine by SUDOSCAN, 30 minuts before hemodialysis.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 17, 2019)
Cutaneous conductance to chlorine by SUDOSCAN after hemiodialysis [ Time Frame: Day 1 ]
This outcome is to measure cutaneous conductance to chlorine by SUDOSCAN, 30 minuts after hemodialysis.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Abnormalities of the Nervous System in the Occurrence of Intradialytic Arterial Hypotension
Official Title  ICMJE Study of Abnormalities of the Vegetative Nervous System in the Occurrence of Intradialytic Arterial Hypotension
Brief Summary

Intradialytic hypotension is a common complication of hemodialysis sessions in patients with chronic renal failure, with an estimated prevalence of 10 to 30%. This hypotensopn is classically defined by a decrease in systolic blood pressure greater than 30 mmHg associated with clinical signs (cramps, abdominal pain, unconsciousness, convulsions). Its repetition is correlated with cardiovascular events, neurological events and excess mortality. Several clinical factors have been proposed to predict the risk of intradialytic hypotension such as age, certain comorbidities (diabetes, ischemic heart disease...), dialysis modalities (hemodialysis), ultrafiltration, conductivity but also alterations of the autonomic nervous system (especially the sympathetic system).

In recent years, the study of vegetative functions has been facilitated by the use of SUDOSCAN® (Impeto, Paris, France) which is a simple, non-invasive tool that allows the study of Chlorine conductance directly reflecting the activity of small non-myelinated C fibers that innervate the sweat glands. SUDOSCAN® has shown good sensitivity and specificity in the diagnosis of vegetative damage in diabetic patients and also a good correlation with cardiac autonomic neuropathy. More recently, SUDOSCAN® has shown good sensitivity in the detection of neuropathies small fibers especially in diabetic patients. This sensitivity is comparable to QST-type quantitative tests and the correlation with cardiovascular dysautonomia tests is good. This test, simple and fast realization, does not require the active participation of the patient. There is a good correlation between the results of SUDOSCAN® and the reduction of intra-dermal fiber density at cutaneous biopsy.

Hemodialysis patients are at risk of peripheral neurological involvement not only because of an increasing incidence of diabetes (30-40%) but also because of the abnormal production and elimination of certain uremic toxins. Few studies exist on the anomalies of the vegetative system in hemodialysis. A recent publication has suggested a difference in nerve excitability depending on the type of hemodialysis suggesting nerve changes secondary to ionic changes. The identification of patients at risk of intradialytic hypotension during dialysis sessions could be useful for adapting hemodialysis protocols.

Patients will be classified into 2 groups according to the occurrence of intradialytic hypotension. Group 1 corresponds to patients with intradialytic hypotension and group 2 corresponds to patients without intradialytic hypotension.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Patients will be classified into 2 groups according to the occurrence of intradialytic hypotension which is defined as a decrease in systolic blood pressure greater than 30 mmHg associated with clinical signs (cramps, abdominal pain, unconsciousness, convulsions). Group 1 corresponds to patients with intradialytic hypotension and group 2 corresponds to patients without intradialytic hypotension. This study aims to measure the cutaneous conductance to chlorine by SUDOSCAN® in all dialysis patients and to seek a link between the results of this examination and the occurrence of discomfort during hemodialysis sessions.
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Hemodialysis Complication
Intervention  ICMJE Diagnostic Test: Cutaneous conductance to chlorine by SUDOSCAN
The additional examination, related to this research protocol, corresponds to a record of cutaneous conductance with chlorine. This recording of 2 min 30 is done thanks to SUDOSCAN® within 30 minutes before the dialysis session (before the "connection" to the dialysis machine) and within 30 minutes after the end of the dialysis with a measurement of the tension blood pressure and heart rate immediately before SUDOSCAN®.
Study Arms  ICMJE
  • Experimental: Group 1: patients without intradialytic hypotension
    The investigators will measure the cutaneous conductance to chlorine by SUDOSCAN® in all dialysis patients without intradialytic hypotension and to seek a link between the results of this examination and the occurrence of discomfort during hemodialysis sessions.
    Intervention: Diagnostic Test: Cutaneous conductance to chlorine by SUDOSCAN
  • Experimental: Group 2: patients with intradialytic hypotension
    The investigators will measure the cutaneous conductance to chlorine by SUDOSCAN® in all dialysis patients with intradialytic hypotension and to seek a link between the results of this examination and the occurrence of discomfort during hemodialysis sessions.
    Intervention: Diagnostic Test: Cutaneous conductance to chlorine by SUDOSCAN
Publications * Reach P, Touzot M, Lombardi Y, Maheas C, Sacco E, Fels A, Beaussier H, Ureña-Torres P, Chatellier G, Ridel C, Zuber M. Electrochemical skin conductance by Sudoscan®: a new tool to predict intradialytic hypotension. Nephrol Dial Transplant. 2021 May 21. pii: gfab183. doi: 10.1093/ndt/gfab183. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 17, 2020)
176
Original Estimated Enrollment  ICMJE
 (submitted: June 17, 2019)
300
Actual Study Completion Date  ICMJE May 11, 2021
Actual Primary Completion Date May 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patient whose age ≥ 18 years
  • Patient on hemodialysis for more than 6 months
  • Patient affiliated with a health insurance plan
  • Francophone patient
  • Patient giving free, informed and express consent

Exclusion Criteria:

  • Patient with lesions, wounds, amputations preventing the measurement of the chlorine conductance of the palms of the hands and feet
  • Patient with a disability that prevents them from standing while measuring conductance / SUDOSCAN®
  • Patient already included in an interventional research protocol
  • Patient under tutorship or curatorship
  • Patient deprived of liberty
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03990142
Other Study ID Numbers  ICMJE SUDHEMO
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Groupe Hospitalier Paris Saint Joseph
Study Sponsor  ICMJE Groupe Hospitalier Paris Saint Joseph
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Pauline REACH, MD Groupe Hospitalier Paris Saint Joseph
PRS Account Groupe Hospitalier Paris Saint Joseph
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP