Condition category
Surgery
Date applied
28/05/2010
Date assigned
04/11/2010
Last edited
09/09/2016
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 Helen Jefferies

ORCID ID

Contact details

Department of Renal Medicine
Royal Derby Hospital
Uttoxeter Road
Derby
DE22 3NE
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RD-5103-013-07

Study information

Scientific title

A randomised controlled cross-over trial of 0.5 mmol/L versus 1.0 mmol/L dialysate magnesium to abrogate dialysis-induced myocardial stunning

Acronym

Study hypothesis

Increasing dialysate magnesium will abrogate dialysis-induced myocardial stunning.

Ethics approval

Trent Research Ethics Committee, 04/09/2008, ref: 08/H0405/42

Study design

Randomised controlled cross-over trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

Dialysis-induced myocardial stunning

Intervention

Each patient undergoes one week (three dialysis treatments) of standard haemodialysis, and one week (three dialysis treatments) of standard haemodialysis with supplemental oxygen to breathe; the chronological order of the two weeks is allocated by randomisation. Patients thereby act as their own controls. Monitored visits occur on the third treatment of each week. There is no further follow-up.

Intervention type

Drug

Phase

Not Applicable

Drug names

Dialysate magnesium

Primary outcome measures

Development of regional wall motion abnormalities.
Key observations are taken pre-dialysis (baseline), 15 minutes prior to end of dialysis (peak stress) by cardiac echocardiography (for later offline semi-automated analysis for regional wall motion abnormalities).

Secondary outcome measures

Haemodynamic variables observed pre-dialysis, and throughout dialysis treatment, with continuous non-invasive measurement by finometer, and NICOM (bioreactance).

Overall trial start date

01/06/2008

Overall trial end date

01/11/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Over 18 years old, either sex
2. Chronic haemodialysis greater than 3 months

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

24

Participant exclusion criteria

1. New York Heart Association (NYHA) grade IV heart failure
2. Cardiac transplant
3. Known disorder of magnesium metabolism
4. Magnesium supplementation
5. Recent arrhythmia

Recruitment start date

01/06/2008

Recruitment end date

01/11/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Renal Medicine
Derby
DE22 3NE
United Kingdom

Sponsor information

Organisation

Derby Hospitals NHS Foundation Trust (UK)

Sponsor details

Royal Derby Hospital
Uttoxeter Road
Derby
DE22 3NE
United Kingdom

Sponsor type

Government

Website

http://www.derbyhospitals.nhs.uk/

Funders

Funder type

Charity

Funder name

Kidney Research UK (UK) (ref: RP5/2008)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

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

09/09/2016: No publications found in PubMed, verifying study status with principal investigator.