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The new Uplug° technology, interface between the end of the hemodialysis catheter and the dialysis circuit, makes it possible to limit direct access to the hemodialysis catheter during connections and disconnections.
Aim:
The investigators propose a feasibility study, in order to study the new Uplug° technology in real conditions of use.
Material and methods:
This study aim to include 15 hemodialysis patients in a center on a tunneled permanent central venous hemodialysis catheter. The Uplug° technology will be placed at the end of each patient's hemodialysis catheter for a period of one month.
Hypothesis tested:
The main endpoint is the proportion of hemodialysis sessions performed successfully with this technology, respecting the usual dialysis prescription.
The incidence and prevalence of chronic insufficiency have been growing for several years. Increasingly older patients are treated with chronic hemodialysis. The vascular access of choice remains the arteriovenous fistula and the proportion of hemodialysis patients on the permanent central venous hemodialysis catheter varies from 20 to 35% in dialysis centres. The new Uplug° technology, interface between the end of the hemodialysis catheter and the dialysis circuit, makes it possible to limit direct access to the hemodialysis catheter during connections and disconnections.
Aim:
The investigators propose a feasibility study, in order to study the new Uplug° technology in real conditions of use.
Material and methods:
This study aim to include 15 hemodialysis patients in a center on a tunneled permanent central venous hemodialysis catheter. The inclusion period is three months. The follow-up time for each participant is 6 weeks. Patients with a tunneled permanent central venous hemodialysis catheter and performing dialysis sessions with a flow rate ≥ 300 ml/min may be included. The Uplug° technology will be placed at the end of each patient's hemodialysis catheter for a period of one month.
Hypothesis tested:
The main endpoint is the proportion of hemodialysis sessions performed successfully with this technology, respecting the usual dialysis prescription.
The secondary objectives are the infectious risk, the defects of the experimental device and the hemodialysis catheter or their implementation, the satisfaction of the nursing staff and the patient, the reduction in the number of manipulations and the effective time of these manipulations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| use of the device during hemodialysis sessions | Experimental | use of the device during one month during hemodialysis sessions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UPLUG Hemodialysis Connection Device | Device | use of the device UPLUG during 1 month |
|
| Measure | Description | Time Frame |
|---|---|---|
| success in performing dialysis | Study the feasibility of performing dialysis with the UPlug Technology in patients with a permanent tunneled central venous hemodialysis catheter with the objective of a success rate ≥ 80%. | one month |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Adverse Events [Safety and Tolerability] of the experimental device UPLUG | adverse events reported from consent to end of study | one month |
| experimental device integrity |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Caen Normandie | Caen | 14000 | France |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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feasibility study on medical device
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device deficiencies reported from consent to end of study
| one month |
| nurses' satisfaction | satisfaction evaluated by questionnaire before and after the inclusions | one month |
| patient satisfaction | satisfaction evaluated by questionnaire before and after the use of experimental device | one month |
| clinical performance of device | performance measured by rate of successful sessions | one month |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |