Impact of Dialysis Modality

NCT07479888 | Completed

• 2 other identifiers: 2021/207/OB2021-A01788-33
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Dialysis

Keywords

ischemia critical lower limb; Chronic Hemodialysis

Outcome Measures

Primary Outcomes (1)

• 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 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

  1 years

• Evaluation of the association between the use of peridialysis in cases of critical ischemia and the risk of amputation at 12 months

  1 years

• Determine the risk factors for transitioning to critical ischemia during dialysis

  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

  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

  1 years

Interventions

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients undergoing chronic hemodialysis

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (1)

University Rouen Hospital

Rouen, 76031, France

Location

Study Officials

• Mélanie MH HANOY, Doctor

  University Rouen Hospiotal, Service de Néphrologie

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2026
• First Posted: March 18, 2026
• Study Start: December 6, 2021
• Primary Completion: June 2, 2024
• Study Completion: June 1, 2025
• Last Updated: March 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)