Transcapillary Plasma Refill in Advanced Chronic Kidney Disease

NCT ID: NCT03348488

Last Updated: 2019-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-01

Study Completion Date

2019-03-08

Brief Summary

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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.

Detailed Description

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Conditions

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Haemodynamic Instability

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

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

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standard ultrafiltration

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

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type ACTIVE_COMPARATOR

Ultrafiltration dose

Intervention Type PROCEDURE

Fixed high volume of ultrafiltration over an hour during dialysis

Interventions

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Ultrafiltration dose

Fixed high volume of ultrafiltration over an hour during dialysis

Intervention Type PROCEDURE

Other Intervention Names

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Ultrafiltration rate

Eligibility Criteria

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Inclusion Criteria

* Prevalent haemodialysis patient at CMFT and satellite units

Exclusion Criteria

* Withdrawal of consent.
* Inability to provide informed consent.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Manchester

OTHER

Sponsor Role collaborator

Manchester Metropolitan University

OTHER

Sponsor Role collaborator

University of Birmingham

OTHER

Sponsor Role collaborator

Manchester University NHS Foundation Trust

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sandip Mitra

Role: PRINCIPAL_INVESTIGATOR

Manchester University NHS Foundation Trust

Locations

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Manchester University NHS Foundation Trust

Manchester, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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R04305

Identifier Type: -

Identifier Source: org_study_id

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