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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-A01788-33 | Other Identifier | ANSM |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| 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 |
| 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.. |
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Inclusion Criteria:
Exclusion Criteria:
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patients undergoing chronic hemodialysis
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| Name | Affiliation | Role |
|---|---|---|
| Mélanie MH HANOY, Doctor | University Rouen Hospiotal, Service de Néphrologie | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Rouen Hospital | Rouen | 76031 | France |
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| 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 |