Impact of Dialysis Modality (HICMI)

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.

Study Overview

• Status: Completed
• Conditions: Dialysis
• Intervention / Treatment: Diagnostic test: Evaluation of the occurrence of critical lower limb ischemia during dialysis in patients undergoing chronic hemodialysis

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 Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• France
  • Rouen, France, 76031
    • University Rouen Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

patients undergoing chronic hemodialysis

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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..	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.	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).	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..	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..	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..	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..	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..	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..	1 years

Collaborators and Investigators

• Sponsor: University Hospital, Rouen
• Investigators: Principal Investigator: Mélanie MH HANOY, Doctor, University Rouen Hospiotal, Service de Néphrologie

Study record dates

Study Major Dates

• Study Start (Actual): December 6, 2021
• Primary Completion (Actual): June 2, 2024
• Study Completion (Actual): June 1, 2025

Study Registration Dates

• First Submitted: February 12, 2026
• First Submitted That Met QC Criteria: March 13, 2026
• First Posted (Actual): March 18, 2026

Study Record Updates

• Last Update Posted (Actual): March 18, 2026
• Last Update Submitted That Met QC Criteria: March 13, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Chronic Hemodialysis; ischemia critical lower limb
• Other Study ID Numbers: 2021/207/OB; 2021-A01788-33 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No