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Completed

NCT Number: NCT07479888

Impact of Dialysis Modality

* 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.

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Key information

Conditions

Dialysis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Rouen Hospital

Rouen, 76031, France

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Evaluation of the occurrence of critical lower limb ischemia during dialysis in patients undergoing chronic hemodialysis

Diagnostic 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

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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

    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..

  2. 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

    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.

  3. Determine the risk factors for transitioning to critical ischemia during dialysis

    Time frame: 2 weeks

    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).

  4. 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

    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..

  5. 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

    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..

  6. 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

    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..

  7. 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

    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..

  8. 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

    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..

  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

    Time frame: 1 years

    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..

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Official study title

Impact of Dialysis Modality on the Occurrence of Peridialytic Critical Limb Ischemia in Chronic Hemodialysis Patients

Acronym: HICMI

Important dates

Study start
2021
Primary completion
2024
Study completion
2025
First posted
Mar 18, 2026
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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