Dialysis
Conditions
Keywords
ischemia critical lower limb, Chronic Hemodialysis
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.
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.
Interventions
DIAGNOSTIC_TESTEvaluation of the occurrence of critical lower limb ischemia during dialysis in patients undergoing chronic hemodialysis
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
Sponsors
University Hospital, Rouen
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the dialysis modality in patients undergoing chronic hemodialysis | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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.. |
| Evaluation of the association between the use of peridialysis in cases of critical ischemia and the risk of amputation at 12 months | 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. |
| Determine the risk factors for transitioning to critical ischemia during dialysis | 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). |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORMélanie MH HANOY, Doctor
University Rouen Hospiotal, Service de Néphrologie
Outcome results
None listed