Clinical trial NCT01947829: Interdialytic Kt/V Variability Measurement With Adimea (IVP STUDY)
Official title: Interdialytic Kt/V Variability Measurement With Adimea (IVP STUDY)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Disease
Keywords: hemodialysis
dialysis dose
Lead sponsor: B.Braun Avitum AG
Sponsor class: INDUSTRY
First posted: 2013-09-23
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients on chronic hemodialysis.

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.


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

Primary outcomes:
measure: Dialysis dose (spKt/V) measured by Adimea and Urea Kinetic Modeling (UKM)
timeFrame: Six months prospective
Secondary outcomes:
measure: Treatment time
timeFrame: Six months prospective
measure: Blood flow rate
timeFrame: 6 months prospective
measure: Dialysate flow rate
timeFrame: 6 months prospective
measure: Ultrafiltration volume
timeFrame: 6 months prospective
measure: Dialyser size
timeFrame: 6 months prospective
measure: Hemoglobin
timeFrame: 6 months prospective
measure: Hematocrit
timeFrame: 6 months prospective
measure: Intact parathyroid hormone (iPTH)
timeFrame: 6 months prospective
measure: C-reactive protein (CRP)
timeFrame: 6 months prospective
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Friendship Hospital,Capital Medical University
city: Beijing
country: China
facility: China PLA General Hospital (301 hospital)
Study officials:
affiliation: China PLA General Hospital (301 hospital)
name: Xiangmei Chen, Prof.
role: PRINCIPAL_INVESTIGATOR
References: