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
Secondary identifying numbers AN05/6839
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

Not provided at time of registration

Contact information

Dr Simon Turner
Scientific

Academic Unit of Anaesthesia
Brotherton Wing
Leeds General Infirmary
Leeds
LS1 3EX
United Kingdom

+44 (0)113 3926363
s.turner@leeds.ac.uk

Study information

Study designDouble blind randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typePrevention
Scientific title
Study hypothesisThat 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
ConditionAbdominal aortic aneurysm
Intervention10 mg/kg methylprednisolone or dextrose placebo in equal volume given before ischaemia and subsequent reperfusion
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)methylprednisolone
Primary outcome measureUrinary 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).
Secondary outcome measuresUrinary 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).
Overall study start date01/06/2005
Overall study end date01/06/2006

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexNot Specified
Target number of participants20
Participant inclusion criteriaPatients 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.
Participant exclusion criteriaPatients 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
Recruitment start date01/06/2005
Recruitment end date01/06/2006

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Academic Unit of Anaesthesia
Leeds
LS1 3EX
United Kingdom

Sponsor information

Leeds General Infirmary (UK)
Hospital/treatment centre

c/o Dr Johanathan Gower
6th Floor Wellcome Wing
Leeds General Infirmary
Leeds
LS1 3EX
England
United Kingdom

http://www.leedsteachinghospitals.com/patients/aboutus/hospitals/lgi.php
ROR logo https://ror.org/04hrjej96

Funders

Funder type

Research organisation

The Association of Anaesthetists of Great Britain and Ireland (UK)

No information available

Anaesthetic Research Society (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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
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