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.: PACTR201512001367808 Date of Approval: 27/11/2015
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Subanaesthetic dose of Ketamine in attenuating ischemia reperfusion injury in adult living donor liver transplant.
Official scientific title The effect of subanaesthetic dose of Ketamine in attenuating ischemia reperfusion injury in adult living donor liver transplant. A randomised controlled study.
Brief summary describing the background and objectives of the trial During transplantation, the liver is subjected to ischaemia and reperfusion injury IRI which causes early transplant failures and can lead to acute and chronic rejection, moreover IRI associated with intra-and/or extrahepatic non anastomotic biliary complications following liver transplantation therefore reducing or prevention of IRI is acentral strategy for an improvement of short term as well as long term graft performance after transplantation. The objective is to test the effect of using asubanesthetic dose of ketamine administered during the dissection phase in recepients undergoing ALDLT and monitor the inflammatory process mainly by TNF alpha,IL-6,NFk beta and ROS, And monitor the post operative complications.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Circulatory System,Liver transplantation
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/10/2015
Actual trial start date 19/08/2015
Anticipated date of last follow up 31/10/2016
Actual Last follow-up date 31/10/2016
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants) 40
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 was variable minimum of 4) 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 Ketamine 0.5-0.7 mg/kg Once During the dissection phase 20
Control Group Control Saline Once During the dissection phase 20 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- American Society of Anesthesiologists physical status class II - III. - MELD score between 15-20. - Ketamine hypersensitivity . - Haemodynamic instability. - Preoperative acute bacterial infection. 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
No 01/08/2015 Menoufyia University, National Liver Institute (NLI), IRB
Ethics Committee Address
Street address City Postal code Country
Yassin abd elghafar Shebin elkoom Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Interlukein 6 After one hr and After 24 hrs from administration of ketamine hydrochloride
Secondary Outcome SVR (dyne/second/centimeter-5) T0 : base line, before induction of anesthesia. T1 : 1 hr after reperfusion phase. T2 : 24 hrs after reperfusion phase.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
National Liver Institute Yassin abdolghafar Shebin elkoom Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
National Liver Institute Yassin abdolghafar Shebin elkoom Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor National Liver Institute Yassin abdolghafar Shebin elkoom Egypt University
COLLABORATORS
Name Street address City Postal code Country
Ahmed Abd-Elraouf Metwaly Yassin abdolghafar Shebin elkoom Egypt
Khaled Ahmed Yassen Yassin abdolghafar Shebin elkoom Egypt
Amany Said Ammar Yassin abdolghafar Shebin elkoom Egypt
Naglaa Mostafa Hussein Yassin abdolghafar Shebin elkoom Egypt
Manar Serageldeen Mohammed El-Esaly Yassin abdolghafar Shebin elkoom Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Khaled Yassen kyassen61@hotmail.com 002-010-63080170 Yassin abdolghafar
City Postal code Country Position/Affiliation
Shebin elkoom Egypt Professor of Anesthesiology and Intensive Care
Role Name Email Phone Street address
Public Enquiries Elsayedamr Basma elsayedamr@yahoo.com 00201223106023 30 Garden City Smouha
City Postal code Country Position/Affiliation
Alexandria 21516 Egypt Patient Information Manager
Role Name Email Phone Street address
Scientific Enquiries Ahmed Metwaly drahmedabdelraouf@yahoo.com 002-01227968325 Yassin abdolghafar
City Postal code Country Position/Affiliation
Shebin elkoom 21516 Egypt Professor of Anesthesiology 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