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.: PACTR201404000809236 Date of Approval: 05/04/2014
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Magnesium and haemodynamic changes associated with right lobe live donor hepatectomy
Official scientific title title:Effect of magnesium on haemodynamic changes associated with right lobe live donor hepatectomy
Brief summary describing the background and objectives of the trial living donor liver transplantation is the only definitive management of patients of end stage liver disease Liver resection is considered as a major operation that involves intraoperative haemodynamic changes in the form of elevated cardiac output, increase in heart rate, cardiac index and stroke volume and moderate pulmonary oedema. The donors are subjected to intraoperative haemodynamic changes attributed to liver resection. We try to detect the effect of magnesium sulfate the haemodynamic changes and anasthetic requirement intraoperative and post operative
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Digestive System,Right lobe live donor hepatectomy,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/06/2013
Actual trial start date 01/08/2013
Anticipated date of last follow up 31/05/2014
Actual Last follow-up date 20/05/2014
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants) 50
Recruitment status Closed to recruitment,follow-up continuing
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 =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 Magnesium infusion group 30 mg kg¿1 and 10 mg /kg/ h by continuous infusion over the entire operation period magnesium 25
Control Group Saline infusion group over the entire operation period control 25 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
ASA classification I normal liver function tests, renal function tests and serum electrolytes Preoperative breathlessness on physical exercise. Any central nervous system disease. Severe haemodynamic instability at the end of the operation. Unwilling to participate in the study 18 Year(s) 40 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 01/06/2013 National Liver Institute IRB
Ethics Committee Address
Street address City Postal code Country
Yassin abd elghafar street SHEBIN el kom Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Heamodynamic (hr,BP,CVP,CPO,CI,SV) Each intraoperative hour
Secondary Outcome Serum Na ,K and Mg Complete blood picture Stander coagulation test: (prothrombin time, concentration and partial thromboplastin time) ABG Before operation
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
National Liver Institute, Menoufiya University Yassin abd elghafar street SHEBIN el kom Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
National Liver Institute, Menoufiya University Yassin abd elghafar street SHEBIN el kom 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 SHEBIN el kom Egypt University
COLLABORATORS
Name Street address City Postal code Country
Khaled Ahmed Yassen Yassin abd elghafar street SHEBIN el kom Egypt
Ghada mahmoud mohamed Yassin abd elghafar street SHEBIN el kom Egypt
Eman said Yassin abd elghafar street SHEBIN el kom Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Khaled Yassen khaledyassen61@hotmail.com 002-01063080170 Yassin abd elghafar street
City Postal code Country Position/Affiliation
SHEBIN el kom Egypt Professor of Anesthesia 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 Ghada mahmoud dr.dodim@yahoo.com 002-01024595554 Yassin abd elghafar street
City Postal code Country Position/Affiliation
SHEBIN el kom Egypt Doctor of Anaesthesia
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