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

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.

Study Overview

• Status: Completed
• Conditions: Kidney Disease

• Study Type: Observational
• Enrollment (Actual): 120

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100050
    • Beijing Friendship Hospital,Capital Medical University
  • Beijing, China, 100853
    • China PLA General Hospital (301 hospital)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients on chronic hemodialysis.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Chronic Hemodialysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Dialysis dose (spKt/V) measured by Adimea and Urea Kinetic Modeling (UKM)	Six months prospective

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment time	Dialysis time per session	Six months prospective
Blood flow rate	Initial blood flow rate [ml/min] at the beginning of dialysis session.	6 months prospective
Dialysate flow rate	Initial dialysate flow rate [ml/min] at the beginning of dialysis session.	6 months prospective
Ultrafiltration volume	Ultrafiltration volume [ml] reached at the end of dialysis session.	6 months prospective
Dialyser size	Membrane surface size [m2] of the dialyser used during dialysis session.	6 months prospective
Hemoglobin	Hemoglobin level [mmol/l or g/dl] before dialysis.	6 months prospective
Hematocrit	Hematocrit level [%] before dialysis.	6 months prospective
Intact parathyroid hormone (iPTH)	Intact parathyroid hormone level [pmol/l or ng/l] before dialysis.	6 months prospective
C-reactive protein (CRP)	C-reactive protein level [mg/l or g/dl] before dialysis.	6 months prospective

Collaborators and Investigators

• Sponsor: B.Braun Avitum AG
• Investigators: Principal Investigator: Xiangmei Chen, Prof., China PLA General Hospital (301 hospital)

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: September 18, 2013
• First Submitted That Met QC Criteria: September 20, 2013
• First Posted (Estimate): September 23, 2013

Study Record Updates

• Last Update Posted (Estimate): November 23, 2016
• Last Update Submitted That Met QC Criteria: November 22, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: hemodialysis; dialysis dose
• Additional Relevant MeSH Terms: Urologic Diseases; Kidney Diseases
• Other Study ID Numbers: BA-O-H-1205