Transcapillary Plasma Refill in Advanced Chronic Kidney Disease

NCT03348488 | Completed

• 1 other identifier: R04305
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Haemodynamic Instability

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Standard ultrafiltration

NO INTERVENTION

standard ultrafiltration (fluid removal from the body by dialysis at the prescribed volume and rate) during a conventional treatment

High dose ultrafiltration

ACTIVE COMPARATOR

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

Interventions

Ultrafiltration dose PROCEDURE

Fixed high volume of ultrafiltration over an hour during dialysis

Also known as: Ultrafiltration rate

High dose ultrafiltration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Prevalent haemodialysis patient at CMFT and satellite units

You may not qualify if:

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

Sponsors & Collaborators

• Manchester University NHS Foundation Trust: lead
• University of Manchester: collaborator
• Manchester Metropolitan University: collaborator
• University of Birmingham: collaborator

Study Sites (1)

Manchester University NHS Foundation Trust

Manchester, M13 9WL, United Kingdom

Location

Study Officials

• Sandip Mitra

  Manchester University NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: August 21, 2017
• First Posted: November 21, 2017
• Study Start: September 1, 2016
• Primary Completion: March 8, 2019
• Study Completion: March 8, 2019
• Last Updated: August 15, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)