ClinicalTrials.Veeva

Menu

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

B. Braun logo

B. Braun

Status

Completed

Conditions

Kidney Disease

Study type

Observational

Funder types

Industry

Identifiers

NCT01947829
BA-O-H-1205

Details and patient eligibility

About

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.

Enrollment

120 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

120 participants in 1 patient group

Chronic Hemodialysis

Trial contacts and locations

2

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems