Interdialytic Kt/V Variability Measurement With Adimea (IVP STUDY)

Study Overview
=================
Brief Summary
-----------------
Session-to-session variations in delivered Kt/V that may cause failure to achieve the prescribed dialysis dose may be significant in regular clinical practice. To date, this is not recognized due to monthly blood Kt/V measurements only. Suboptimal delivery of prescribed dialysis dose may be caused by low effective treatment time, vascular access dysfunction, hemodynamic stability, blood pump speed, membrane influences, lab value variability or others which may vary from session to session. Patients close to recommended target limits of dialysis dose may thus be randomly attributed to be adequately or inadequately dialyzed. Therefore, in the literature, use of average Kt/V values is recommended. Adimea allows easy Kt/V determination in every session and thus documentation of the monthly achieved Kt/V in patients who repeatedly miss Kt/V. Knowledge, therefore, of session-to-session variability as well as knowledge of dialysis dose monitoring at every dialysis may enhance and secure delivery of adequate dialysis. The main objective is the estimation of the pooled within-patient SDs (standard deviation) for single treatment Adimea and of urea kinetic modeling (UKM)/ blood spKt/V. Failure of Kt/V>1.2 delivery as well as its potential causes will be assessed. spKt/V target achievement is assessed by monitoring dose by Adimea at every dialysis. This shall demonstrate that session-to-session variability can be decreased with usage of Adimea.

Official Title
-----------------
Interdialytic Kt/V Variability Measurement With Adimea (IVP STUDY)

Conditions
-----------------
Kidney Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient on chronic hemodialysis for at least 6 months Thrice dialysis therapy weekly Stable fistula access Documented three, monthly blood spKt/V from 1.0 to 1.4 or Average of spKt/V<1.35 out of three consecutive blood measurements Age ≥ 18 years Voluntary participation and written informed consent Exclusion Criteria: Severe hematologic disorders (e.g. multiple myeloma) Life expectancy less than 6 months Single-needle dialysis Patient was monitored with Adimea

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Chronic Hemodialysis<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dialysis dose (spKt/V) measured by Adimea and Urea Kinetic Modeling (UKM) |  | Six months prospective | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment time | Dialysis time per session | Six months prospective | 
| Blood flow rate | Initial blood flow rate [ml/min] at the beginning of dialysis session. | 6 months prospective | 
| Dialysate flow rate | Initial dialysate flow rate [ml/min] at the beginning of dialysis session. | 6 months prospective | 
| Ultrafiltration volume | Ultrafiltration volume [ml] reached at the end of dialysis session. | 6 months prospective | 
| Dialyser size | Membrane surface size [m2] of the dialyser used during dialysis session. | 6 months prospective | 
| Hemoglobin | Hemoglobin level [mmol/l or g/dl] before dialysis. | 6 months prospective | 
| Hematocrit | Hematocrit level [%] before dialysis. | 6 months prospective | 
| Intact parathyroid hormone (iPTH) | Intact parathyroid hormone level [pmol/l or ng/l] before dialysis. | 6 months prospective | 
| C-reactive protein (CRP) | C-reactive protein level [mg/l or g/dl] before dialysis. | 6 months prospective | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hemodialysis, dialysis dose