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

NCT01947829 | Completed

• 1 other identifier: BA-O-H-1205
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 2

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.

Conditions

Kidney Disease

Keywords

hemodialysis; dialysis dose

Outcome Measures

Primary Outcomes (1)

• Dialysis dose (spKt/V) measured by Adimea and Urea Kinetic Modeling (UKM)

  Six months prospective

Secondary Outcomes (9)

• Treatment time

  Six months prospective

• Blood flow rate

  6 months prospective

• Dialysate flow rate

  6 months prospective

• Ultrafiltration volume

  6 months prospective

• Dialyser size

  6 months prospective

Study Arms (1)

Chronic Hemodialysis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients on chronic hemodialysis.

You may qualify if:

• 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

You may not qualify if:

• Severe hematologic disorders (e.g. multiple myeloma)
• Life expectancy less than 6 months
• Single-needle dialysis
• Patient was monitored with Adimea

Sponsors & Collaborators

• B.Braun Avitum AG: lead

Study Sites (2)

Beijing Friendship Hospital,Capital Medical University

Beijing, 100050, China

Location

China PLA General Hospital (301 hospital)

Beijing, 100853, China

Location

MeSH Terms

Conditions

Kidney Diseases

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Xiangmei Chen, Prof.

  China PLA General Hospital (301 hospital)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2013
• First Posted: September 23, 2013
• Study Start: October 1, 2013
• Primary Completion: December 1, 2014
• Last Updated: November 23, 2016

Record last verified: 2016-11

Locations

CN (2)