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ISRCTN
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ISRCTN71629284
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ClinicalTrials.gov identifier
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Public title
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Does N-Acetylcysteine (Parvolex®) prophylaxis reduce the incidence of renal impairment after onpump Coronary Artery Bypass Graft surgery? A prospective randomised controlled trial
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Scientific title
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Acronym
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N-Acetylcysteine prophylaxis for onpump CABG
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Serial number at source
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07/Q1403/17
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Study hypothesis
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Prohylatic use of N-Acetylcysteine will decrease the incidence of renal failure in patients undergoing onpump Coronary Artery Bypass Graft (CABG) surgery.
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Lay summary
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Not provided at time of registration
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Ethics approval
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Approved by South Manchester Research Ethics Committee (UK) on the 18th June 2007 (REC ref 07/Q1403/17).
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Study design
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Prospective randomised double blind controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Renal impairment
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Participants - inclusion criteria
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1. Patients undergoing elective coronoray artery bypass surgery (onpump) at Wythenshawe Hospital
2. Aged 21 - 80 years
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Participants - exclusion criteria
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1. Urgent or emergency cases
2. History of hypersensitivity to N-Acetylcysteine
3. Patients already taking N-Acetylcysteine
4. Patients with renal failure
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Anticipated start date
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01/08/2007
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Anticipated end date
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31/07/2008
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Status of trial
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Stopped |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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224 (112 in each group) (Trial stopped in September 2010)
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Interventions
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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.
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Primary outcome measure(s)
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Creatinine clearance and serum creatinine levels on second and fifth post operative day and on discharge.
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Secondary outcome measure(s)
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Length of Intensive Care Unit (ICU) stay.
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Sources of funding
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University Hospital of South Manchester NHS Foundation Trust (UK)
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Trial website
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Publications
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Contact name
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Dr
Donna
Greenhalgh
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Address
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Consultant Anaesthetist
Wythenshawe Hospital
South Moore Road
Wythenshawe
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City/town
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Manchester
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Zip/Postcode
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M23 9LT
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Country
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United Kingdom
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Tel
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+44 (0)161 291 2525
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Email
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donna.greenhalgh@btopenworld.com
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Sponsor
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University Hospital of South Manchester NHS Foundation Trust (UK)
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Address
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Department of Research and Development
Wythenshawe Hospital
South Moore Road
Wythenshawe
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City/town
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Manchester
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Zip/Postcode
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M23 9LT
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Country
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United Kingdom
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Tel
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+44 (0)161 291 5775
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Email
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andrew.maines@manchester.ac.uk
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Sponsor website:
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http://www.smuht.nwest.nhs.uk/
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Date applied
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08/07/2007
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Last edited
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07/02/2012
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Date ISRCTN assigned
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21/08/2007
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