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

Completed

• Conditions: Kidney Disease

• Registration Number: NCT01947829
• Lead Sponsor: B.Braun Avitum AG

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-09-18
• Study First Submitted QC: 2013-09-20
• Study First Posted: 2013-09-23
• Study Start: 2013-10
• Primary Completion: 2014-12
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-22
• Last Update Posted: 2016-11-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Dialysis dose (spKt/V) measured by Adimea and Urea Kinetic Modeling (UKM)	Six months prospective

Secondary Outcome Measures

Name	Time	Method
Dialyser size	6 months prospective	Membrane surface size \[m2\] of the dialyser used during dialysis session.
Hematocrit	6 months prospective	Hematocrit level \[%\] before dialysis.
Treatment time	Six months prospective	Dialysis time per session
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.
Dialysate flow rate	6 months prospective	Initial dialysate flow rate \[ml/min\] at the beginning of dialysis session.
Blood flow rate	6 months prospective	Initial blood 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.
Hemoglobin	6 months prospective	Hemoglobin level \[mmol/l or g/dl\] before dialysis.

Trial Locations

Locations (2)

Beijing Friendship Hospital,Capital Medical University; 🇨🇳 Beijing, China

China PLA General Hospital (301 hospital); 🇨🇳 Beijing, China