search
Back to results

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

Primary Purpose

Hemodialysis Complication

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Cutaneous conductance to chlorine by SUDOSCAN
Sponsored by
Fondation Hôpital Saint-Joseph
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hemodialysis Complication

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • AURA Paris Plaisance

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group 1: patients without intradialytic hypotension

Group 2: patients with intradialytic hypotension

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Cutaneous conductance to chlorine by SUDOSCAN before hemiodialysis
This outcome is to measure cutaneous conductance to chlorine by SUDOSCAN, 30 minuts before hemodialysis.

Secondary Outcome Measures

Cutaneous conductance to chlorine by SUDOSCAN after hemiodialysis
This outcome is to measure cutaneous conductance to chlorine by SUDOSCAN, 30 minuts after hemodialysis.

Full Information

First Posted
June 17, 2019
Last Updated
May 28, 2021
Sponsor
Fondation Hôpital Saint-Joseph
search

1. Study Identification

Unique Protocol Identification Number
NCT03990142
Brief Title
Study of Abnormalities of the Nervous System in the Occurrence of Intradialytic Arterial Hypotension
Acronym
SUDHEMO
Official Title
Study of Abnormalities of the Vegetative Nervous System in the Occurrence of Intradialytic Arterial Hypotension
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
June 25, 2019 (Actual)
Primary Completion Date
May 31, 2020 (Actual)
Study Completion Date
May 11, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondation Hôpital Saint-Joseph

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemodialysis Complication

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Non-Randomized
Enrollment
176 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1: patients without intradialytic hypotension
Arm Type
Experimental
Arm Description
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.
Arm Title
Group 2: patients with intradialytic hypotension
Arm Type
Experimental
Arm Description
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 Type
Diagnostic Test
Intervention Name(s)
Cutaneous conductance to chlorine by SUDOSCAN
Intervention Description
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®.
Primary Outcome Measure Information:
Title
Cutaneous conductance to chlorine by SUDOSCAN before hemiodialysis
Description
This outcome is to measure cutaneous conductance to chlorine by SUDOSCAN, 30 minuts before hemodialysis.
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Cutaneous conductance to chlorine by SUDOSCAN after hemiodialysis
Description
This outcome is to measure cutaneous conductance to chlorine by SUDOSCAN, 30 minuts after hemodialysis.
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pauline REACH, MD
Organizational Affiliation
Fondation Hôpital Saint-Joseph
Official's Role
Principal Investigator
Facility Information:
Facility Name
AURA Paris Plaisance
City
Paris
ZIP/Postal Code
75014
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
34021358
Citation
Reach P, Touzot M, Lombardi Y, Maheas C, Sacco E, Fels A, Beaussier H, Urena-Torres P, Chatellier G, Ridel C, Zuber M. Electrochemical skin conductance by Sudoscan(R): a new tool to predict intradialytic hypotension. Nephrol Dial Transplant. 2021 Jul 23;36(8):1511-1518. doi: 10.1093/ndt/gfab183.
Results Reference
result

Learn more about this trial

Study of Abnormalities of the Nervous System in the Occurrence of Intradialytic Arterial Hypotension

We'll reach out to this number within 24 hrs