Condition category
Urological and Genital Diseases
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
16/06/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr CW McIntyre

ORCID ID

Contact details

Southern Derbyshire Acute Hospitals NHS Trust
Department of Nephrology
Derby City General Hospital
Uttoxeter Road
Derby
DE22 3NE
United Kingdom
+44 (0)1332 340131

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0077122814

Study information

Scientific title

Acronym

Study hypothesis

1. Haemodialysis with ultrafiltration is capable of inducing myocardial stunning in individuals both with and without coronary artery disease
2. Myocardial stunning induced by haemodialysis may be ameliorated by the use of biofeedback-controlled haemodialysis, despite identical total ultrafiltration

Ethics approval

Not provided at time of registration

Study design

Randomised crossover study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Urological and Genital Diseases: Haemodialysis

Intervention

We propose to study chronic haemodialysis patients in a randomised crossover study.
The first group will undergo an initial period of standard haemodialysis followed by a period of biofeedback-controlled haemodialysis.
The second group will do the same in reverse.
At the end of both periods, all patients will undergo echocardiography performed at regular intervals throughout a single haemodialysis session, and for a short period afterwards. They will also have Troponin T measured before and after the same dialysis session.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Number of regional wall abnormalities/patient
2. Ejection and shortening fractions

Secondary outcome measures

Not provided at time of registration

Overall trial start date

21/02/2003

Overall trial end date

01/04/2003

Reason abandoned

Eligibility

Participant inclusion criteria

Patients on chronic haemodialysis

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

21/02/2003

Recruitment end date

01/04/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Southern Derbyshire Acute Hospitals NHS Trust
Derby
DE22 3NE
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

Southern Derbyshire Acute Hospitals NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes