Condition category
Urological and Genital Diseases
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
27/09/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Adrian P Banning

ORCID ID

Contact details

Department of Cardiology
John Radcliffe Hospital
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom
+44 01865 220235
adrian.banning@orh.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0176115665

Study information

Scientific title

Acronym

Study hypothesis

Contrast material administration in cardiac catheterisation (angiogram/angioplasty) is associated with a deterioration in kidney function of some patients with underlying renal impairment. Recent studies suggest that NAC may reduce such complication but it is not clear whether this effect is sustained for long periods or clinically relevant. We therefore would like to propose a study to find out the medium term effect of NAC on the kidney functions of these patients and their clinical relevances. In addition, we would also like to investigate whether there is any significant change in blood markers of inflammation such as vascular cell adhesion molecule-1 (VCAM-1) and isoprostanes with the use of NAC in this group of patients. This may help to explain the mechanism of contrast material induced kidney injury and protective effect of NAC.

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

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Urological and Genital Diseases: Renal function

Intervention

Not provided at time of registration.

Added June 2008: trial abandoned.

Intervention type

Drug

Phase

Not Specified

Drug names

N-acetylcysteine (NAC

Primary outcome measures

1. Change in serum creatinine (short and medium term)
2. VCAM-1 and isoprostanes
3. Length of hospital stay
4. Need for dialysis

Secondary outcome measures

Not provided at time of registration

Overall trial start date

15/07/2002

Overall trial end date

31/05/2004

Reason abandoned

Poor recruitment

Eligibility

Participant inclusion criteria

Not provided at time of registration

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

28 patients, 28 controls, total 56

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

15/07/2002

Recruitment end date

31/05/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Cardiology
Oxford
OX3 9DU
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

Oxford Radcliffe Hospitals NHS 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

Publication citations

Additional files

Editorial Notes