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

Kidney Disease Clinical Trial

— IVP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01947829
• Other study ID #: BA-O-H-1205
• Status: Completed
• Phase: N/A
• First received: September 18, 2013
• Last updated: November 22, 2016
• Start date: October 2013

Study information

• Verified date: November 2016
• Source: B.Braun Avitum AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Kidney Disease
• Kidney Diseases

Locations

Country	Name	City	State
China	Beijing Friendship Hospital,Capital Medical University	Beijing
China	China PLA General Hospital (301 hospital)	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
B.Braun Avitum AG

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dialysis dose (spKt/V) measured by Adimea and Urea Kinetic Modeling (UKM)		Six months prospective	No
Secondary	Treatment time	Dialysis time per session	Six months prospective	No
Secondary	Blood flow rate	Initial blood flow rate [ml/min] at the beginning of dialysis session.	6 months prospective	No
Secondary	Dialysate flow rate	Initial dialysate flow rate [ml/min] at the beginning of dialysis session.	6 months prospective	No
Secondary	Ultrafiltration volume	Ultrafiltration volume [ml] reached at the end of dialysis session.	6 months prospective	No
Secondary	Dialyser size	Membrane surface size [m2] of the dialyser used during dialysis session.	6 months prospective	No
Secondary	Hemoglobin	Hemoglobin level [mmol/l or g/dl] before dialysis.	6 months prospective	No
Secondary	Hematocrit	Hematocrit level [%] before dialysis.	6 months prospective	No
Secondary	Intact parathyroid hormone (iPTH)	Intact parathyroid hormone level [pmol/l or ng/l] before dialysis.	6 months prospective	No
Secondary	C-reactive protein (CRP)	C-reactive protein level [mg/l or g/dl] before dialysis.	6 months prospective	No