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Transcapillary Plasma Refill in Advanced Chronic Kidney Disease

An Investigation of Transcapillary Plasma Refill During Ultrafiltration in Haemodialysis

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03348488
Acronym
PRUf
Enrollment
24
Registered
2017-11-21
Start date
2016-09-01
Completion date
2019-03-08
Last updated
2019-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Haemodynamic Instability

Brief summary

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.

Interventions

PROCEDUREUltrafiltration dose

Fixed high volume of ultrafiltration over an hour during dialysis

Sponsors

University of Manchester
CollaboratorOTHER
Manchester Metropolitan University
CollaboratorOTHER
University of Birmingham
CollaboratorOTHER
Manchester University NHS Foundation Trust
Lead SponsorOTHER_GOV

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

The 2 arms applied to the same subject studied twice (case controlled)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Prevalent haemodialysis patient at CMFT and satellite units

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Plasma refilling rateContinuous derivation of the refilling rate during a four hour haemodialysis treatmentTo assess absolute plasma volume changes during ultrafiltration on haemodialysis

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026