To investigate the effect of methylprednisolone on inflammatory cytokines and urinary N-Beta-D-glucosaminidase/creatinine ratio in elective aortic aneurysm repair
| ISRCTN | ISRCTN21626059 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN21626059 |
| Protocol serial number | AN05/6839 |
| Sponsor | Leeds General Infirmary (UK) |
| Funders | The Association of Anaesthetists of Great Britain and Ireland (UK), Anaesthetic Research Society (UK) |
- Submission date
- 08/03/2007
- Registration date
- 30/04/2007
- Last edited
- 24/03/2011
- 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
Dr Simon Turner
Scientific
Scientific
Academic Unit of Anaesthesia
Brotherton Wing
Leeds General Infirmary
Leeds
LS1 3EX
United Kingdom
| Phone | +44 (0)113 3926363 |
|---|---|
| s.turner@leeds.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Double blind randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | That methylprednisolone given before ischaemia and subsequent reperfusion may attenuate renal damage in patients undergoing elective open aortic aneurysm repair |
| Ethics approval(s) | Leeds West Local ethics committee, approved on 4 April 2005. Ref: 05/Q1205/31 |
| Health condition(s) or problem(s) studied | Abdominal aortic aneurysm |
| Intervention | 10 mg/kg methylprednisolone or dextrose placebo in equal volume given before ischaemia and subsequent reperfusion |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | methylprednisolone |
| Primary outcome measure(s) |
Urinary N-acetyl-beta-D-glucosaminidase (Beta-NAG) levels over the first post operative week (at baseline, 1 hour, 2, 6, 24 and 48 hours post cross clamp release). |
| Key secondary outcome measure(s) |
Urinary albumin and alpha-1 microglobulin levels over the first post operative week (at baseline, 1 hour, 2, 6, 24 and 48 hours post cross clamp release). |
| Completion date | 01/06/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target sample size at registration | 20 |
| Key inclusion criteria | Patients presenting to the Vascular Unit for elective abdominal aortic aneurysm repair will be invited to take part. Patients will be aged between 18 and 75. |
| Key exclusion criteria | Patients will be free to withdraw from the study at any time without having to give any reason and without prejudice to clinical care. 1. Diabetic patients 2. Active proven infection 3. Already on steroids 4. Systemic fungal infection 5. Acute renal failure 6. On renal replacement therapy 7. Pregnant or lactating |
| Date of first enrolment | 01/06/2005 |
| Date of final enrolment | 01/06/2006 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Academic Unit of Anaesthesia
Leeds
LS1 3EX
United Kingdom
LS1 3EX
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 | 01/01/2008 | Yes | No |
