Interdialytic Kt/V Variability Measurement With Adimea (IVP STUDY)
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Chronic Hemodialysis
|
Outcome Measures
Primary Outcome Measures
- Dialysis dose (spKt/V) measured by Adimea and Urea Kinetic Modeling (UKM) [Six months prospective]
Secondary Outcome Measures
- Treatment time [Six months prospective]
Dialysis time per session
- Blood flow rate [6 months prospective]
Initial blood flow rate [ml/min] at the beginning of dialysis session.
- Dialysate flow rate [6 months prospective]
Initial dialysate flow rate [ml/min] at the beginning of dialysis session.
- Ultrafiltration volume [6 months prospective]
Ultrafiltration volume [ml] reached at the end of dialysis session.
- Dialyser size [6 months prospective]
Membrane surface size [m2] of the dialyser used during dialysis session.
- Hemoglobin [6 months prospective]
Hemoglobin level [mmol/l or g/dl] before dialysis.
- Hematocrit [6 months prospective]
Hematocrit level [%] before dialysis.
- Intact parathyroid hormone (iPTH) [6 months prospective]
Intact parathyroid hormone level [pmol/l or ng/l] before dialysis.
- C-reactive protein (CRP) [6 months prospective]
C-reactive protein level [mg/l or g/dl] before dialysis.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patient on chronic hemodialysis for at least 6 months
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Thrice dialysis therapy weekly
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Stable fistula access
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Documented three, monthly blood spKt/V from 1.0 to 1.4 or
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Average of spKt/V<1.35 out of three consecutive blood measurements
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Age ≥ 18 years
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Voluntary participation and written informed consent
Exclusion Criteria:
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Severe hematologic disorders (e.g. multiple myeloma)
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Life expectancy less than 6 months
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Single-needle dialysis
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Patient was monitored with Adimea
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Beijing Friendship Hospital,Capital Medical University | Beijing | China | 100050 | |
| 2 | China PLA General Hospital (301 hospital) | Beijing | China | 100853 |
Sponsors and Collaborators
- B.Braun Avitum AG
Investigators
- Principal Investigator: Xiangmei Chen, Prof., China PLA General Hospital (301 hospital)
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BA-O-H-1205