Condition category
Urological and Genital Diseases
Date applied
08/07/2007
Date assigned
21/08/2007
Last edited
07/02/2012
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 Donna Greenhalgh

ORCID ID

Contact details

Consultant Anaesthetist
Wythenshawe Hospital
South Moore Road
Wythenshawe
Manchester
M23 9LT
United Kingdom
+44 (0)161 291 2525
donna.greenhalgh@btopenworld.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

07/Q1403/17

Study information

Scientific title

Acronym

N-Acetylcysteine prophylaxis for onpump CABG

Study hypothesis

Prohylatic use of N-Acetylcysteine will decrease the incidence of renal failure in patients undergoing onpump Coronary Artery Bypass Graft (CABG) surgery.

Ethics approval

Approved by South Manchester Research Ethics Committee (UK) on the 18th June 2007 (REC ref 07/Q1403/17).

Study design

Prospective randomised double blind controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Renal impairment

Intervention

For both groups, there will be no change in routine anaesthetic/surgical or post operative management.

The intervention group will be administered 2 g N-Acetylcysteine on the night before surgery (oral), 2 g at induction of anaesthesia (intravenous [IV]) and 2 g IV on the morning of first post operative day. The control group will receive placebos at the same time as the intervention group.

Patients will be followed up until discharge.

As of 07/02/2012, the trial was stopped in September 2010 due to problems with recruitment and the delay resulted in the trial being out of date.

Intervention type

Drug

Phase

Not Specified

Drug names

N-Acetylcysteine (Parvolex®)

Primary outcome measures

Creatinine clearance and serum creatinine levels on second and fifth post operative day and on discharge.

Secondary outcome measures

Length of Intensive Care Unit (ICU) stay.

Overall trial start date

01/08/2007

Overall trial end date

31/07/2008

Reason abandoned

"Participant recruitment issue"

Eligibility

Participant inclusion criteria

1. Patients undergoing elective coronoray artery bypass surgery (onpump) at Wythenshawe Hospital
2. Aged 21 - 80 years

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

224 (112 in each group) (Trial stopped in September 2010)

Participant exclusion criteria

1. Urgent or emergency cases
2. History of hypersensitivity to N-Acetylcysteine
3. Patients already taking N-Acetylcysteine
4. Patients with renal failure

Recruitment start date

01/08/2007

Recruitment end date

31/07/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Consultant Anaesthetist
Manchester
M23 9LT
United Kingdom

Sponsor information

Organisation

University Hospital of South Manchester NHS Foundation Trust (UK)

Sponsor details

Department of Research and Development
Wythenshawe Hospital
South Moore Road
Wythenshawe
Manchester
M23 9LT
United Kingdom
+44 (0)161 291 5775
andrew.maines@manchester.ac.uk

Sponsor type

Government

Website

http://www.smuht.nwest.nhs.uk/

Funders

Funder type

Government

Funder name

University Hospital of South Manchester 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

Publication citations

Additional files

Editorial Notes