NCT01947829

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 120 (actual)
• Sponsor: B.Braun Avitum AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Kidney Disease

Timeline

• Start date: 2013-10-01
• Primary completion: 2014-12-01
• First posted: 2013-09-23
• Last updated: 2016-11-23

Locations

2 sites across 1 country: China