Perioperative renal protection in patients subject to cardio-pulmonary bypass
| ISRCTN | ISRCTN66959365 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN66959365 |
| Secondary identifying numbers | N0123138282 |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 25/04/2014
- 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
Mr T Spyt
Scientific
Scientific
University Hospitals of Leicester
c/o Research and Development Office
Leicester General Hospital NHS Trust
Leicester
LE1 4PW
United Kingdom
| Phone | +44 (0)116 258 4109 |
|---|
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Screening |
| Scientific title | |
| Study objectives | To examine potential methods of protecting the kidney during and immediately after heart surgery using cardiopulmonary bypass. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Cardiopulmonary bypass |
| Intervention | To examine potential methods of protecting the kidney during and immediately after heart surgery using cardiopulmonary bypass. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Determine whether perioperative low dose frusemide, dopamine or aminophylline would improve clinical and biochemical outcomes in adult patients, at increased risk of kidney dysfunction. |
| Secondary outcome measures | No secondary outcome measures |
| Overall study start date | 01/01/2003 |
| Completion date | 01/04/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 60 patients, 20 controls |
| Key inclusion criteria | 1. Aged greater than 70 years 2. Pre-existing renal disease 3. Not on renal replacement therapy 4. Pre-operative serum creatinine greater than 130 umol/l 5. Type one diabetes mellitus |
| Key exclusion criteria | Only first time coronary artery surgery will be included |
| Date of first enrolment | 01/01/2003 |
| Date of final enrolment | 01/04/2003 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
University Hospitals of Leicester
Leicester
LE1 4PW
United Kingdom
LE1 4PW
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
University Hospitals of Leicester NHS Trust (UK)
No information available
Departmental funding (UK)
No information available
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 |
