Condition category
Surgery
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
18/02/2008
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

Mr J Boyle

ORCID ID

Contact details

Cambridge Vascular Unit
Dept. of General Surgery
Box 201
Addenbrooke's Hospital
Cambridge
CB2 2QQ
United Kingdom
+44 (0)1223 217246
jonathan.boyle@addenbrookes.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0544139644

Study information

Scientific title

Acronym

Study hypothesis

Is peri-operative oral N acetylcysteine nephroprotective in patients undergoing endovascular abdominal aortic aneurysm repair?

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Surgery: Abdominal aortic aneurysm (AAA) repair

Intervention

Participation offered to all patients undergoing endovascular abdominal aortic aneurysm repair in the Cambridge Vascular Unit, Addenbrooke's Hospital. Consenting patients will be randomised to receive either intra venous saline hydration (current practice) or intravenous saline hydration and oral N acetyl-cysteine (600 mg twice a day (bd) orally (PO) on the day before the procedure; and 600 mg bd PO on the day of the procedure, one dose before, and one dose after the procedure). Evidence of renal injury will be monitored post-procedure by assay of serum creatinine levels, and also by measuring urinary low molecular weight proteins such as N acetyl beta glucosaminidase (NAG) a subclinical marker of renal injury, and albumin and creatinine.

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

16/12/2003

Overall trial end date

15/12/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Not provided at time of registration

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

20

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

16/12/2003

Recruitment end date

15/12/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Cambridge Vascular Unit
Cambridge
CB2 2QQ
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Cambridge Consortium - Addenbrooke's (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

2006 results on http://www.ncbi.nlm.nih.gov/pubmed/17042662

Publication citations

  1. Results

    Moore NN, Lapsley M, Norden AG, Firth JD, Gaunt ME, Varty K, Boyle JR, Does N-acetylcysteine prevent contrast-induced nephropathy during endovascular AAA repair? A randomized controlled pilot study., J. Endovasc. Ther., 2006, 13, 5, 660-666, doi: 10.1583/06-1833.1.

Additional files

Editorial Notes