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OpenTrials
Completed

NCT Number: NCT03348488

Transcapillary Plasma Refill in Advanced Chronic Kidney Disease

Background: Haemodynamic instability during haemodialysis has long been linked to poor cardiovascular outcomes. It does not always reflect overall hydration but rather plasma volume depletion, with a delay in plasma refill from other body compartments, and vasodilatation, mediated by endothelial factors. Our understanding of these processes remains largely incomplete. Despite our ability to monitor relative blood volume during haemodialysis our knowledge concerning the factors affecting plasma refill remain incomplete. This may be due to variations observed between individuals. Understanding the pattern of fluid shifts variation between the different body compartment and the factors affecting these behaviours in different individuals or at different hydration states could be a vital component of our management of intradialytic haemodynamic instability but also overhydration.

Aims and Objectives: The aim of this study is to describe plasma refill rate, during haemodialysis using a non-invasive, continuous, real-time data capture during ultrafiltration. The study will attempt to describe different refilling phenotypes in the study population and seek association with biochemical and haematological parameters linked to variability in refilling rates.

Methodology: This study will attempt to describe variations in the plasma refill rate of prevalent dialysis patients during their normal haemodialysis treatment and during a session of 3 hours of haemodialysis preceded by 1 hour of isolated ultrafiltration using the in-built blood volume monitoring module of their haemodialysis machine and the TMON software that collects continuous, real-time data by interfacing with the computer network. To achieve this, a bolus of 100-300ml of intravenous dialysis replacement fluid will be administered at the beginning of each of the 2 studied sessions.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Manchester University NHS Foundation Trust

Manchester, M13 9WL, United Kingdom

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Prevalent haemodialysis patient at CMFT and satellite units

Exclusion criteria

  • Withdrawal of consent.
  • Inability to provide informed consent.

Treatment and study plan

Ultrafiltration dose

Procedure

Fixed high volume of ultrafiltration over an hour during dialysis

Other names: Ultrafiltration rate

Primary outcomes

  1. Plasma refilling rate

    Time frame: Continuous derivation of the refilling rate during a four hour haemodialysis treatment

    To assess absolute plasma volume changes during ultrafiltration on haemodialysis

Sponsors and collaborators

Lead sponsor

Manchester University NHS Foundation Trust

Other Gov

Collaborators

  • Manchester Metropolitan University
  • University of Birmingham
  • University of Manchester

Registry information

Official study title

An Investigation of Transcapillary Plasma Refill During Ultrafiltration in Haemodialysis

Acronym: PRUf

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Nov 21, 2017
Registry last updated
Aug 15, 2019

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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