Transcapillary Plasma Refill in Advanced Chronic Kidney Disease (PRUf)

An Investigation of Transcapillary Plasma Refill During Ultrafiltration in Haemodialysis

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.

Study Overview

• Status: Completed
• Conditions: Haemodynamic Instability
• Intervention / Treatment: Procedure: Ultrafiltration dose

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Manchester, United Kingdom, M13 9WL
    • Manchester University NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Prevalent haemodialysis patient at CMFT and satellite units

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard ultrafiltration; standard ultrafiltration (fluid removal from the body by dialysis at the prescribed volume and rate) during a conventional treatment
Active Comparator: High dose ultrafiltration; Intervention= Fixed rate high dose ultrafiltration (fluid removed from the body by dialysis) of 1 litre per hour over 1 hr instaed of standard ultrafiltration rate and volume.	Procedure: Ultrafiltration dose; Fixed high volume of ultrafiltration over an hour during dialysis; Other Names: Ultrafiltration rate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma refilling rate	To assess absolute plasma volume changes during ultrafiltration on haemodialysis	Continuous derivation of the refilling rate during a four hour haemodialysis treatment

Collaborators and Investigators

• Sponsor: Manchester University NHS Foundation Trust
• Collaborators: Manchester Metropolitan University; University of Manchester; University of Birmingham
• Investigators: Principal Investigator: Sandip Mitra, Manchester University NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): March 8, 2019
• Study Completion (Actual): March 8, 2019

Study Registration Dates

• First Submitted: August 21, 2017
• First Submitted That Met QC Criteria: November 17, 2017
• First Posted (Actual): November 21, 2017

Study Record Updates

• Last Update Posted (Actual): August 15, 2019
• Last Update Submitted That Met QC Criteria: August 14, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: R04305

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No