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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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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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Completed |
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Patient information material
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Target number of participants
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224 (112 in each group)
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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.
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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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21/08/2007
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Date ISRCTN assigned
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21/08/2007
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