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
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