Hemodialysis ComplicationSUDHEMONCT03990142
Study of Abnormalities of the Nervous System in the Occurrence of Intradialytic Arterial Hypotension
A study testing Cutaneous conductance to chlorine by SUDOSCAN in people with Hemodialysis Complication, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodialysis Complication
- What is being tested?
- Cutaneous conductance to chlorine by SUDOSCAN
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 1 siteFrance
- Study dates
- 25 Jun 2019to 11 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Abnormalities of the Vegetative Nervous System in the Occurrence of Intradialytic Arterial Hypotension
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.
Read more
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.
- Conditions
- Hemodialysis Complication
- Being tested
- Cutaneous conductance to chlorine by SUDOSCAN
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cutaneous conductance to chlorine by SUDOSCANDiagnostic test
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 group | Role | What they receive |
|---|---|---|
| Group 1: patients without intradialytic hypotension | Experimental | 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. Receives: Diagnostic Test: Cutaneous conductance to chlorine by SUDOSCAN |
| Group 2: patients with intradialytic hypotension | Experimental | 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. Receives: Diagnostic Test: Cutaneous conductance to chlorine by SUDOSCAN |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cutaneous conductance to chlorine by SUDOSCAN before hemiodialysis
This outcome is to measure cutaneous conductance to chlorine by SUDOSCAN, 30 minuts before hemodialysis.
Measured: Day 1
Secondary outcomes (1)
Cutaneous conductance to chlorine by SUDOSCAN after hemiodialysis
This outcome is to measure cutaneous conductance to chlorine by SUDOSCAN, 30 minuts after hemodialysis.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2019
- Study start25 Jun 2019
- Primary completion31 May 2020
- Study completion11 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hemodialysis ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pauline REACH, MD, Principal investigator, Fondation Hôpital Saint-Joseph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03990142
- Sponsor's protocol ID
- SUDHEMO
- Acronym
- SUDHEMO
- Status last verified
- May 2021
- First submitted
- 17 Jun 2019
- Last updated
- 2 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34021358
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Abnormalities of the Vegetative Nervous System in the Occurrence of Intradialytic Arterial Hypotension
- ClinicalTrials.gov ID
- NCT03990142
- Acronym / sponsor ID
- SUDHEMO / SUDHEMO
- Conditions
- Hemodialysis Complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 25 Jun 2019 (actual)
- Primary completion
- 31 May 2020 (actual)
- Study completion
- 11 May 2021 (actual)
- First posted
- 18 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group 1: patients without intradialytic hypotension | Experimental | Diagnostic Test: Cutaneous conductance to chlorine by SUDOSCANThe 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. |
| Group 2: patients with intradialytic hypotension | Experimental | Diagnostic Test: Cutaneous conductance to chlorine by SUDOSCANThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cutaneous conductance to chlorine by SUDOSCANThe 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®. | Diagnostic test | Group 1: patients without intradialytic hypotension, Group 2: patients with intradialytic hypotension |
Primary outcome
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.
1 secondary outcome
Cutaneous conductance to chlorine by SUDOSCAN after hemiodialysis
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2021.
- Results publication: PubMed 34021358Reach 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pauline REACH, MD principal investigator
Fondation Hôpital Saint-Joseph
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cutaneous conductance to chlorine by SUDOSCAN in people with Hemodialysis Complication, run by Fondation Hôpital Saint-Joseph at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cutaneous conductance to chlorine by SUDOSCAN before hemiodialysis (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03990142, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2021.