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.: PACTR201508001251260 Date of Approval: 30/08/2015
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title THE EFFECT OF INTRA AND POSTOPERATIVE INTRAVENOUS INFUSION OF N- ACETYLCYSTEINE IN CIRRHOTIC PATIENTS UNDERGOING LIVER RESECTION: A PROSPECTIVE RANDO
Official scientific title THE EFFECT OF INTRA AND POSTOPERATIVE INTRAVENOUS INFUSION OF N- ACETYLCYSTEINE IN CIRRHOTIC PATIENTS UNDERGOING LIVER RESECTION: A PROSPECTIVE RANDOMISED CONTROLLED STUDY
Brief summary describing the background and objectives of the trial post-operative hepatic dysfunction is common in cirrhotic patients undergoing liver resection. We prospectively evaluate the effectiveness of the intra and post operative intravenous infusion of N-Acetylcysteine in improving postoperative outcome in cirrhotic patients undergoing liver resection.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cirrhotic patients undergoing liver resection,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/03/2015
Actual trial start date 01/03/2015
Anticipated date of last follow up 01/03/2016
Actual Last follow-up date 01/03/2016
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
Recruitment status Recruiting
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 Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group N-Acetylcysteine 10 gram NAC 72 hrs. 10 gram NAC over 24hr in 250cc glucose 5% until postoperative day 2 30
Control Group Controls glucose 5% 72 hrs. similar volume of glucose 5% 30 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Adult cirrhotic patients undergoing liver resection. - American Society of Anesthesiologists physical status class I-II. - Child Pugh classification "A and early B" - Patients with severe cardiovascular disease. - History of bronchial asthma. - Drug allergy to NAC. 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 01/03/2014 National liver institute
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 ALT - Baseline, - Post-resection, - Postoperative day D1 - Postoperative day D3
Secondary Outcome Haemodynamics Intra and post operative for 7 days
Secondary Outcome oxygen delivery and consumption - Baseline, - Post-resection, - Postoperative day D1 - Postoperative day D3
Secondary Outcome ICAM1 blood levels - Baseline, - Post-resection, - Postoperative day D1 - Postoperative day D3
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
National Liver Institute, Menoufiya University Yassin abd elghafar street Shebeen El-koom Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
National Liver Institute, Menoufiya University 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, Menoufiya University Yassin abd elghafar street Shebeen El.koom Egypt University
COLLABORATORS
Name Street address City Postal code Country
Khaled Ahmed Yassen Yassin abd elghafar street Shebeen El.koom Egypt
Hatem Amin Attalla Yassin abd elghafar street Shebeen El.koom Egypt
Eman Sayed Ibrahim Yassin abd elghafar street Shebeen El.koom Egypt
Khaled Mohammed Gaballah Yassin abd elghafar street Shebeen El.koom Egypt
Eman Saied Younes Yassin abd elghafar street Shebeen El.koom Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Khaled Yassin kyassen61@hotmail.com 002-01063080170 Kafr abdo
City Postal code Country Position/Affiliation
Alexandria Egypt Professor of anesthesia and surgical 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 Hatem Attalla kyassen61@hotmail.com 002-01063080170 Yassin abd elghafar street
City Postal code Country Position/Affiliation
SHEBIN el kom Egypt Ass. professor of Anaesthesia and Intensive Care
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information