DialysisHICMINCT07479888
Impact of Dialysis Modality
An observational study of Dialysis, run by University Hospital, Rouen at 1 site in France.
Trial summary
Peripheral Arterial Disease (PAD) is a common condition in patients with End-Stage Renal Failure (ESRF) undergoing dialysis. Late diagnosis of PAD and hypoperfusion induced by dialysis sessions explain the high morbidity and mortality associated with this condition in hemodialysis patients compared to the general… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dialysis
- What is being tested?
- Evaluation of the occurrence of critical lower limb ischemia during dialysis in patients undergoing chronic hemodialysis
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 6 Dec 2021to 1 Jun 2025
- How long will I take part?
- 2 Weeks
- Phase
- Observational
- 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
Study population: patients undergoing chronic hemodialysis
Who may be able to join
- Patient must be an adult (aged 18 years or older)
- Must have been on chronic hemodialysis for at least 3 months
- Must be willing to undergo one week of daily hemodialysis to assess its clinical benefit
- Must have read and understood the information letter and agree to participate in the study
Who cannot join
- Bilateral amputation including the big toes
- Hemodynamic instability defined by a peridialytic blood pressure drop of more than 50% of sessions
- Patient undergoing acute hemodialysis
- Contraindication to either of the two dialysis modalities
- Patient not wishing to undergo daily hemodialysis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Dialysis Modality on the Occurrence of Peridialytic Critical Limb Ischemia in Chronic Hemodialysis Patients
- Peripheral Arterial Disease (PAD) is a common condition in patients with End-Stage Renal Failure (ESRF) undergoing dialysis.
- Late diagnosis of PAD and hypoperfusion induced by dialysis sessions explain the high morbidity and mortality associated with this condition in hemodialysis patients compared to the general population.
- The main objective of this study is to evaluate whether a dialysis modality (conventional 4-hour sessions 3 times per week or daily 2-hour sessions 6 times per week) is more effective in preventing the progression of critical limb ischemia during dialysis and thus preventing serious complications of PAD.
This study will help define a population of chronic hemodialysis patients at risk of developing critical limb ischemia during dialysis sessions. This will allow us to offer them the dialysis modality that best maintains distal perfusion of the lower limbs and may prevent the onset of trophic disorders.
Read the detailed description
- The hypothesis of this project is that daily hemodialysis would provide better stability of distal lower limb perfusion compared to 4-hour intermittent hemodialysis: because ultrafiltration is short and daily, vascular filling from the interstitial space to the plasma space is optimized, reducing the risk of sudden hypovolemia, which is detrimental to microcirculation. Furthermore, the improved hemodynamic tolerance of ultrafiltration results in less of a drop in blood pressure, which can lead to distal hypoperfusion.
- To validate this hypothesis, this study measured the systolic blood pressure at the great toe (SBP) by photoplethysmography several times during a 4-hour dialysis session and then several times during a 2-hour daily dialysis session. This technique allows for the detection of critical limb ischemia in dialysis patients with good sensitivity. The judgment criterion will be the transition to critical ischemia defined by a PSGO of less than 30 mmHg or less than 50 mmHg in the presence of trophic disorders.
This study should enable the recommendation of switching to daily hemodialysis for patients at risk of developing critical limb ischemia on conventional 4-hour intermittent hemodialysis. The objective is to prevent the onset of trophic disorders, the consequences of which in terms of morbidity and mortality are dramatic.
- Conditions
- Dialysis
- Being tested
- Evaluation of the occurrence of critical lower limb ischemia during dialysis in patients undergoing chronic hemodialysis
- Keywords
- ischemia critical lower limb, Chronic Hemodialysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of the occurrence of critical lower limb ischemia during dialysis in patients undergoing chronic hemodialysisDiagnostic test
It will be assessed whether a dialysis modality (conventional 4-hour session 3 times a week or daily 2-hour session 6 times a week) allows for greater prevention of perialysis of the lower limbs in critical ischemia defined by a pressure at the big toe < 30 mmHg or 50 mmHg in the presence of trophic disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the dialysis modality in patients undergoing chronic hemodialysis
Evaluate whether a dialysis modality (conventional 4-hour session 3 times a week or daily 2-hour session 6 times a week) allows for greater prevention of perialytic progression of the lower limbs into critical ischemia defined by a pressure at the big toe < 30 mmHg or 50 mmHg in the presence of trophic disorders. The primary endpoint is the transition to critical ischemia on at least one of the repeated measurements during the dialysis session (H1, H2, H3, H4) of the Great Toe Systolic Pressure (GTSP) determined by plethysmography (GTSP < 30 mmHg or less than 50 mmHg in the presence of trophic disorders).
Measured: 2 weeks
Secondary outcomes (9)
Evaluation of the association between the transition to critical ischemia during dialysis and the occurrence of fatal and non-fatal cardiovascular events at one year
Participants will be followed clinically for one year after enrollment in the study to identify the occurrence of any major adverse cardiovascular event, defined as the first occurrence of one of the following:
- Myocardial infarction (fatal or non-fatal) Events will be prospectively recorded during scheduled follow-up visits and as part of dialysis adherence monitoring..
Measured: 1 years
Evaluation of the association between the use of peridialysis in cases of critical ischemia and the risk of amputation at 12 months
This analysis aims to evaluate the association between the initiation of peridialysis in patients with critical limb ischemia and the risk of amputation within one year of enrollment.
The data collected will include the occurrence of any lower limb amputation, regardless of level. Clinical events will be collected prospectively for 12 months after enrollment, during follow-up visits.
Measured: 1 years
Determine the risk factors for transitioning to critical ischemia during dialysis
The transition to critical limb ischemia was determined by non-invasive measurement of the Great Toe Systolic Pressure (GTS) using plethysmography (GTS < 30 mmHg or less than 50 mmHg in the presence of trophic disorders).
Measured: 2 weeks
Evaluation of the association between the transition to critical ischemia during dialysis and the occurrence of fatal and non-fatal cardiovascular events at one year
Participants will be followed clinically for one year after enrollment in the study to identify the occurrence of any major adverse cardiovascular event, defined as the first occurrence of one of the following:
- Ischemic stroke, transient Events will be prospectively recorded during scheduled follow-up visits and as part of dialysis adherence monitoring..
Measured: 1 years
Evaluation of the association between the transition to critical ischemia during dialysis and the occurrence of fatal and non-fatal cardiovascular events at one year
Participants will be followed clinically for one year after enrollment in the study to identify the occurrence of any major adverse cardiovascular event, defined as the first occurrence of one of the following:
- transient ischemic attack (TIA) Events will be prospectively recorded during scheduled follow-up visits and as part of dialysis adherence monitoring..
Measured: 1 years
Evaluation of the association between the transition to critical ischemia during dialysis and the occurrence of fatal and non-fatal cardiovascular events at one year
Participants will be followed clinically for one year after enrollment in the study to identify the occurrence of any major adverse cardiovascular event, defined as the first occurrence of one of the following:
- established stroke Events will be prospectively recorded during scheduled follow-up visits and as part of dialysis adherence monitoring..
Measured: 1 years
Evaluation of the association between the transition to critical ischemia during dialysis and the occurrence of fatal and non-fatal cardiovascular events at one year
Participants will be followed clinically for one year after enrollment in the study to identify the occurrence of any major adverse cardiovascular event, defined as the first occurrence of one of the following:
- Acute mesenteric ischemia Events will be prospectively recorded during scheduled follow-up visits and as part of dialysis adherence monitoring..
Measured: 1 years
Evaluation of the association between the transition to critical ischemia during dialysis and the occurrence of fatal and non-fatal cardiovascular events at one year
Participants will be followed clinically for one year after enrollment in the study to identify the occurrence of any major adverse cardiovascular event, defined as the first occurrence of one of the following:
- Acute limb ischemia Events will be prospectively recorded during scheduled follow-up visits and as part of dialysis adherence monitoring..
Measured: 1 years
Evaluation of the association between the transition to critical ischemia during dialysis and the occurrence of fatal and non-fatal cardiovascular events at one year
Participants will be followed clinically for one year after enrollment in the study to identify the occurrence of any major adverse cardiovascular event, defined as the first occurrence of one of the following:
- Cardiovascular death Events will be prospectively recorded during scheduled follow-up visits and as part of dialysis adherence monitoring..
Measured: 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study start6 Dec 2021
- Primary completion2 Jun 2024
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DialysisStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
- Target duration
- 2 Weeks
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mélanie MH HANOY, Doctor, Principal investigator, University Rouen Hospiotal, Service de Néphrologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07479888
- Sponsor's protocol ID
- 2021/207/OB
- Other IDs
- 2021-A01788-33
- Acronym
- HICMI
- Status last verified
- Feb 2026
- First submitted
- 12 Feb 2026
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Dialysis Modality on the Occurrence of Peridialytic Critical Limb Ischemia in Chronic Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT07479888
- Acronym / sponsor ID
- HICMI / 2021/207/OB
- Conditions
- Dialysis
- Keywords
- ischemia critical lower limb, Chronic Hemodialysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 6 Dec 2021 (actual)
- Primary completion
- 2 Jun 2024 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 18 Mar 2026 (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.
- Peripheral Arterial Disease (PAD) is a common condition in patients with End-Stage Renal Failure (ESRF) undergoing dialysis.
- Late diagnosis of PAD and hypoperfusion induced by dialysis sessions explain the high morbidity and mortality associated with this condition in hemodialysis patients compared to the general population.
- The main objective of this study is to evaluate whether a dialysis modality (conventional 4-hour sessions 3 times per week or daily 2-hour sessions 6 times per week) is more effective in preventing the progression of critical limb ischemia during dialysis and thus preventing serious complications of PAD.
This study will help define a population of chronic hemodialysis patients at risk of developing critical limb ischemia during dialysis sessions. This will allow us to offer them the dialysis modality that best maintains distal perfusion of the lower limbs and may prevent the onset of trophic disorders.
Detailed description
- The hypothesis of this project is that daily hemodialysis would provide better stability of distal lower limb perfusion compared to 4-hour intermittent hemodialysis: because ultrafiltration is short and daily, vascular filling from the interstitial space to the plasma space is optimized, reducing the risk of sudden hypovolemia, which is detrimental to microcirculation. Furthermore, the improved hemodynamic tolerance of ultrafiltration results in less of a drop in blood pressure, which can lead to distal hypoperfusion.
- To validate this hypothesis, this study measured the systolic blood pressure at the great toe (SBP) by photoplethysmography several times during a 4-hour dialysis session and then several times during a 2-hour daily dialysis session. This technique allows for the detection of critical limb ischemia in dialysis patients with good sensitivity. The judgment criterion will be the transition to critical ischemia defined by a PSGO of less than 30 mmHg or less than 50 mmHg in the presence of trophic disorders.
This study should enable the recommendation of switching to daily hemodialysis for patients at risk of developing critical limb ischemia on conventional 4-hour intermittent hemodialysis. The objective is to prevent the onset of trophic disorders, the consequences of which in terms of morbidity and mortality are dramatic.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 2 Weeks
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients undergoing chronic hemodialysis
Key inclusion criteria (4 listed)
- Patient must be an adult (aged 18 years or older)
- Must have been on chronic hemodialysis for at least 3 months
- Must be willing to undergo one week of daily hemodialysis to assess its clinical benefit
- Must have read and understood the information letter and agree to participate in the study
Key exclusion criteria (5 listed)
- Bilateral amputation including the big toes
- Hemodynamic instability defined by a peridialytic blood pressure drop of more than 50% of sessions
- Patient undergoing acute hemodialysis
- Contraindication to either of the two dialysis modalities
- Patient not wishing to undergo daily hemodialysis
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 |
|---|---|---|
| Evaluation of the occurrence of critical lower limb ischemia during dialysis in patients undergoing chronic hemodialysisIt will be assessed whether a dialysis modality (conventional 4-hour session 3 times a week or daily 2-hour session 6 times a week) allows for greater prevention of perialysis of the lower limbs in critical ischemia defined by a pressure at the big toe < 30 mmHg or 50 mmHg in the presence of trophic disorders | Diagnostic test | – |
Primary outcome
Evaluate the dialysis modality in patients undergoing chronic hemodialysis
Time frame: 2 weeks
Evaluate whether a dialysis modality (conventional 4-hour session 3 times a week or daily 2-hour session 6 times a week) allows for greater prevention of perialytic progression of the lower limbs into critical ischemia defined by a pressure at the big toe < 30 mmHg or 50 mmHg in the presence of trophic disorders. The primary endpoint is the transition to critical ischemia on at least one of the repeated measurements during the dialysis session (H1, H2, H3, H4) of the Great Toe Systolic Pressure (GTSP) determined by plethysmography (GTSP < 30 mmHg or less than 50 mmHg in the presence of trophic disorders).
9 secondary outcomes
Evaluation of the association between the transition to critical ischemia during dialysis and the occurrence of fatal and non-fatal cardiovascular events at one year
Time frame: 1 years
Evaluation of the association between the use of peridialysis in cases of critical ischemia and the risk of amputation at 12 months
Time frame: 1 years
Determine the risk factors for transitioning to critical ischemia during dialysis
Time frame: 2 weeks
Evaluation of the association between the transition to critical ischemia during dialysis and the occurrence of fatal and non-fatal cardiovascular events at one year
Time frame: 1 years
Evaluation of the association between the transition to critical ischemia during dialysis and the occurrence of fatal and non-fatal cardiovascular events at one year
Time frame: 1 years
Evaluation of the association between the transition to critical ischemia during dialysis and the occurrence of fatal and non-fatal cardiovascular events at one year
Time frame: 1 years
Evaluation of the association between the transition to critical ischemia during dialysis and the occurrence of fatal and non-fatal cardiovascular events at one year
Time frame: 1 years
Evaluation of the association between the transition to critical ischemia during dialysis and the occurrence of fatal and non-fatal cardiovascular events at one year
Time frame: 1 years
Evaluation of the association between the transition to critical ischemia during dialysis and the occurrence of fatal and non-fatal cardiovascular events at one year
Time frame: 1 years
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 18 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Mélanie MH HANOY, Doctor principal investigator
University Rouen Hospiotal, Service de Néphrologie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dialysis, run by University Hospital, Rouen 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 4 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 18 Mar 2026. 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?
Evaluate the dialysis modality in patients undergoing chronic hemodialysis (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Mar 2026.