Clinical Trials Directory

Trials / Completed

CompletedNCT03348488

Transcapillary Plasma Refill in Advanced Chronic Kidney Disease

An Investigation of Transcapillary Plasma Refill During Ultrafiltration in Haemodialysis

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
24 (actual)
Sponsor
Manchester University NHS Foundation Trust · Other Government
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREUltrafiltration doseFixed high volume of ultrafiltration over an hour during dialysis

Timeline

Start date
2016-09-01
Primary completion
2019-03-08
Completion
2019-03-08
First posted
2017-11-21
Last updated
2019-08-15

Locations

1 site across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT03348488. Inclusion in this directory is not an endorsement.