Low or high magnesium concentration in intermittent warm blood cardioplegia in patients undergoing coronary artery surgery: a prospective randomised study
| ISRCTN | ISRCTN95530505 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN95530505 |
| Protocol serial number | PG/02/044/13713 |
| Sponsor | British Heart Foundation (UK) |
| Funder | British Heart Foundation (UK) |
- Submission date
- 23/04/2002
- Registration date
- 23/04/2002
- Last edited
- 07/06/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Massimo Caputo
Scientific
Scientific
Bristol Heart Institute
Bristol Royal Infirmary
Marlborough Street
Bristol
BS2 8HW
United Kingdom
| Phone | +44 (0)117 9283145 |
|---|---|
| massimocaputo@hotmail.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | A comparison between two diferent strategies of myocardial protection. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Ischaemic heart disease |
| Intervention | Patients will be randomised to: 1. 5 mmol/l Magnesium (Mg2+) 2. 16 mmol/l Mg2+) In the intermittent antegrade warm blood cardioplegia |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Magnesium |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/12/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 400 |
| Key inclusion criteria | 1. A diagnosis of ischaemic heart disease 2. Undergoing primary myocardial revascularisation with the use of cardiopulmonary bypass and cardioplegic arrest |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/12/2001 |
| Date of final enrolment | 01/12/2004 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Bristol Heart Institute
Bristol
BS2 8HW
United Kingdom
BS2 8HW
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/09/2011 | Yes | No |
