Condition category
Circulatory System
Date applied
08/03/2007
Date assigned
30/04/2007
Last edited
24/03/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Simon Turner

ORCID ID

Contact details

Academic Unit of Anaesthesia
Brotherton Wing
Leeds General Infirmary
Leeds
LS1 3EX
United Kingdom
+44 (0)113 3926363
s.turner@leeds.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

AN05/6839

Study information

Scientific title

Acronym

Study hypothesis

That methylprednisolone given before ischaemia and subsequent reperfusion may attenuate renal damage in patients undergoing elective open aortic aneurysm repair

Ethics approval

Leeds West Local ethics committee, approved on 4 April 2005. Ref: 05/Q1205/31

Study design

Double blind randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Condition

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 names

methylprednisolone

Primary outcome measures

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).

Secondary outcome measures

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).

Overall trial start date

01/06/2005

Overall trial end date

01/06/2006

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

20

Participant 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

Recruitment start date

01/06/2005

Recruitment end date

01/06/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Academic Unit of Anaesthesia
Leeds
LS1 3EX
United Kingdom

Sponsor information

Organisation

Leeds General Infirmary (UK)

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

http://www.leedsteachinghospitals.com/patients/aboutus/hospitals/lgi.php

Funders

Funder type

Research organisation

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Anaesthetic Research Society (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2008 results in: http://www.ncbi.nlm.nih.gov/pubmed/18027383

Publication citations

  1. Results

    Turner S, Derham C, Orsi NM, Bosomworth M, Bellamy MC, Howell SJ, Randomized clinical trial of the effects of methylprednisolone on renal function after major vascular surgery., Br J Surg, 2008, 95, 1, 50-56, doi: 10.1002/bjs.5978.

Additional files

Editorial Notes