Dialysate magnesium - a novel tool to abrogate dialysis-induced myocardial stunning?
| ISRCTN | ISRCTN37809057 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN37809057 |
| Protocol serial number | RD-5103-013-07 |
| Sponsor | Derby Hospitals NHS Foundation Trust (UK) |
| Funder | Kidney Research UK (UK) (ref: RP5/2008) |
- 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
Scientific
Department of Renal Medicine
Royal Derby Hospital
Uttoxeter Road
Derby
DE22 3NE
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled cross-over trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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 |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Dialysate magnesium |
| Primary outcome measure(s) |
Development of regional wall motion abnormalities. |
| Key secondary outcome measure(s) |
Haemodynamic variables observed pre-dialysis, and throughout dialysis treatment, with continuous non-invasive measurement by finometer, and NICOM (bioreactance). |
| Completion date | 01/11/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Department of Renal Medicine
Derby
DE22 3NE
United Kingdom
DE22 3NE
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
09/09/2016: No publications found in PubMed, verifying study status with principal investigator.
