Condition category
Urological and Genital Diseases
Date applied
30/04/2007
Date assigned
02/08/2007
Last edited
06/08/2010
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 Jonathan Boyle

ORCID ID

Contact details

Box 201
Cambridge Vascular Unit
Department of General Surgery
Addenbrooke’s Hospital
Hills Road
Cambridge
CB2 2QQ
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NACP 1

Study information

Scientific title

Acronym

NAC as a Nephroprotective agent in Peripheral Angiography

Study hypothesis

To investigate the role of N-acetylcysteine as a nephroprotective agent in patients undergoing peripheral angiography.

Ethics approval

Ethics approval received from the Cambridge Research Ethics Committee on the 24th November 2006 (ref: 06/QI0108/352).

Study design

Prospective randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Contrast induced nephropathy

Intervention

Treatment group:
Patients will be given 600 mg twice daily N-acetylcysteine the day before the angiogram, and 600 mg twice on the day of the angiogram with intravenous fluids. Samples of urine and blood will be collected before the angiogram and first, second and third day post angiography.

Control group:
Patients will only get intravenous hydration as per normal protocol and will have samples taken like the treatment arm patients.

Intervention type

Drug

Phase

Not Specified

Drug names

N-acetylcysteine

Primary outcome measures

Primarily we are looking for a reduction in the elevation in Albumin/Creatinine ratio and also of other markers of renal damage in urine (retinol binding protein), using the samples collected before the angiogram and first, second and third day post angiography.

Secondary outcome measures

A reduction in the mortality and morbidity related to renal failure that may result secondary to contrast solution used in angiography; this 30-day mortality morbidity reduction will be measured on follow up in clinic normally four to six weeks post angiography.

Overall trial start date

01/05/2007

Overall trial end date

01/05/2008

Reason abandoned

Eligibility

Participant inclusion criteria

Any patient undergoing peripheral angiography in the Cambridge Vascular Unit, Addenbrooke’s Hospital, Cambridge who consents to participation.

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

Initially 40 patients in pilot study

Participant exclusion criteria

1. Any patient undergoing peripheral angiography in Cambridge Vascular Unit
2. Any patient that does not consent to participation in the study
3. Any patient under the age of 18 years
4. Any patient with established renal failure on renal replacement therapy (dialysis)

Recruitment start date

01/05/2007

Recruitment end date

01/05/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Box 201
Cambridge
CB2 2QQ
United Kingdom

Sponsor information

Organisation

Cambridge University Hospital NHS Trust (UK)

Sponsor details

Research & Development Department
Addenbrooke’s Hospital
Cambridge
CB2 2QQ
United Kingdom

Sponsor type

Government

Website

http://www.addenbrookes.org.uk/

Funders

Funder type

Government

Funder name

Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust (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

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20682612

Publication citations

  1. Results

    Sadat U, Walsh SR, Norden AG, Gillard JH, Boyle JR, Does oral N-acetylcysteine reduce contrast-induced renal injury in patients with peripheral arterial disease undergoing peripheral angiography? A randomized-controlled study., Angiology, 2011, 62, 3, 225-230, doi: 10.1177/0003319710377078.

Additional files

Editorial Notes