Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201501001018282 Date of Approval: 27/01/2015
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effectiveness of intravenous infusion of N-Acetylcysteine in cirrhotic patients undergoing major abdominal surgeries
Official scientific title Effectiveness of intravenous infusion of N-Acetylcysteine in cirrhotic patients undergoing major abdominal surgeries
Brief summary describing the background and objectives of the trial Post-operative acute kidney injury (AKI) is common in patients w ith chronic liver disease. We prospectively evaluate effectiveness of the N-Acetylcysteine in preserving postoperative renal functions in cirrhotic patients undergoing major abdominal surgeries.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Digestive System,HCV,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/01/2013
Actual trial start date 01/01/2014
Anticipated date of last follow up 31/10/2014
Actual Last follow-up date 31/10/2014
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomisation (block size of 4 and the block size was not variable) Sealed opaque envelopes Masking/blinding used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomisation (block size of 4 and the block size was not variable) Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group NAcetylcysteine (NAC) 1200 mg of NAcetylcysteine dilute in 5%glucose or physiological solution via an infusion pumpover five hours given immediately after induction of anesthesiafollow ed by additional boluses administe 72 hrs. intravenous bolus of 1200 mg of NAcetylcysteine ( Hidonac 5g & 200mg /ml )( Zambon S.P.A ) dilute in 5%glucose or physiological solution via an infusion pump (Fresenius Kabi, Germany) over five hours given immediately after induction of anesthesia, follow ed by additional boluses administered at 12-hr intervals postoperative for 72 hour in the ICU (total dose of NAC = 7200 mg) 30
Control Group Controls similar volume of glucose 5% bolus and infusion as placebo. 72 hrs. controls received similar volume of glucose 5% bolus and infusion as placebo. 30 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
cirrhotic patients Child A to B scheduled for open major abdominal surgery (intestinal resection, liver resection, w hipple , hepato-biliary procedures) known allergy to NAC having received NAC for contrast-induced nephropathy prevention in the previous 7 days or contrast agents in the previous 72 hrs 18 Year(s) 60 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 01/01/2014 Menoufyia University, National Liver Institute (NLI), IRB
Ethics Committee Address
Street address City Postal code Country
Yassin abd elghafar street Shebeen El.koom Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome serum Cystatin C and Cystatin C GFR preoperative as base and postoperative day
Secondary Outcome liver function tests preoperative as base and postoperative day
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
National liver institute Menoufeya Shebeen El.koom Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
National liver institute Yassin abd elghafar street Shebeen El.koom Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor National liver institute Yassin abd elghafar street Shebeen El.koom Egypt University
COLLABORATORS
Name Street address City Postal code Country
Eman sayed Yassin abd elghafar street Shebeen El.koom Egypt
Ahmed shaarawy Yassin abd elghafar street Shebeen El.koom Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Eman sayed emansayed825@gmail.com 002-01282271464 Yassin abd elghafar street
City Postal code Country Position/Affiliation
SHEBIN el kom Egypt Lecturer of Anaesthesia and Intensive Care
Role Name Email Phone Street address
Public Enquiries Elsayedamr Basma elsayedamr@yahoo.com 002-01223106023 30 Garden City Smouha
City Postal code Country Position/Affiliation
Alexandria 21516 Egypt Patient Information Manager
Role Name Email Phone Street address
Scientific Enquiries Eman sayed emansayed825@gmail.com 002-01282271464 Yassin abd elghafar street
City Postal code Country Position/Affiliation
SHEBIN el kom Egypt Lecturer of Anaesthesia and Intensive Care
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information