Dialysate magnesium - a novel tool to abrogate dialysis-induced myocardial stunning?

ISRCTN	ISRCTN37809057
DOI	https://doi.org/10.1186/ISRCTN37809057
Secondary identifying numbers	RD-5103-013-07

Submission date: 28/05/2010
Registration date: 04/11/2010
Last edited: 09/09/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Helen Jefferies
Scientific

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

Study information

Study design	Randomised controlled cross-over trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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
Study objectives	Increasing dialysate magnesium will abrogate dialysis-induced myocardial stunning.
Ethics approval(s)	Trent Research Ethics Committee, 04/09/2008, ref: 08/H0405/42
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Dialysate magnesium
Primary outcome measure	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 study start date	01/06/2008
Completion date	01/11/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	24
Key inclusion criteria	1. Over 18 years old, either sex 2. Chronic haemodialysis greater than 3 months
Key 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
Date of first enrolment	01/06/2008
Date of final enrolment	01/11/2009

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Department of Renal Medicine

Derby
DE22 3NE
United Kingdom

Sponsor information

Derby Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre

Royal Derby Hospital
Uttoxeter Road
Derby
DE22 3NE
England
United Kingdom

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

Funders

Funder type

Charity

Kidney Research UK (UK) (ref: RP5/2008)
Private sector organisation / Other non-profit organizations

Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

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