Perioperative renal protection in patients subject to cardio-pulmonary bypass
| ISRCTN | ISRCTN66959365 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN66959365 |
| Protocol serial number | N0123138282 |
| Sponsor | Department of Health |
| Funders | University Hospitals of Leicester NHS Trust (UK), Departmental funding (UK) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Determine whether perioperative low dose frusemide, dopamine or aminophylline would improve clinical and biochemical outcomes in adult patients, at increased risk of kidney dysfunction. |
| Key secondary outcome measure(s) |
No secondary outcome measures |
| Completion date | 01/04/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | All |
| Target sample size at registration | 80 |
| 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
- United Kingdom
- England
Study participating centre
University Hospitals of Leicester
Leicester
LE1 4PW
United Kingdom
LE1 4PW
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 |
