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 |
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Hemodialysis Complication | Diagnostic Test: Cutaneous conductance to chlorine by SUDOSCAN | Not Applicable |
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 |
Arm | Intervention/treatment |
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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.
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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®.
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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®.
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
France | |
AURA Paris Plaisance | |
Paris, France, 75014 |
Principal Investigator: | Pauline REACH, MD | Groupe Hospitalier Paris Saint Joseph |
Tracking Information | |||||
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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 |
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.
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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.
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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. |
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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 |
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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®.
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Study Arms ICMJE |
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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. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
176 | ||||
Original Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |
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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 |
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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 |