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Completed

NCT Number: NCT01947829

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Friendship Hospital,Capital Medical University, Beijing, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: Six months prospective

Secondary outcomes

  1. Treatment time

    Time frame: Six months prospective

    Dialysis time per session

  2. Blood flow rate

    Time frame: 6 months prospective

    Initial blood flow rate [ml/min] at the beginning of dialysis session.

  3. Dialysate flow rate

    Time frame: 6 months prospective

    Initial dialysate flow rate [ml/min] at the beginning of dialysis session.

  4. Ultrafiltration volume

    Time frame: 6 months prospective

    Ultrafiltration volume [ml] reached at the end of dialysis session.

  5. Dialyser size

    Time frame: 6 months prospective

    Membrane surface size [m2] of the dialyser used during dialysis session.

  6. Hemoglobin

    Time frame: 6 months prospective

    Hemoglobin level [mmol/l or g/dl] before dialysis.

  7. Hematocrit

    Time frame: 6 months prospective

    Hematocrit level [%] before dialysis.

  8. Intact parathyroid hormone (iPTH)

    Time frame: 6 months prospective

    Intact parathyroid hormone level [pmol/l or ng/l] before dialysis.

  9. C-reactive protein (CRP)

    Time frame: 6 months prospective

    C-reactive protein level [mg/l or g/dl] before dialysis.

Sponsors and collaborators

Lead sponsor

B.Braun Avitum AG

Industry

Registry information

Acronym: IVP

Important dates

Study start
2013
Primary completion
2014
First posted
Sep 23, 2013
Registry last updated
Nov 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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