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.: PACTR201402000752252 Date of Approval: 28/01/2014
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Terlipressin infusion in Living Donor Liver Transplantation
Official scientific title Impact of intra and postoperative terlipressin infusion in patients undergoing Living Donor Liver Transplantation
Brief summary describing the background and objectives of the trial End stage Liver disease is usually accompanied by a decline in systemic vascular resistance (SVR) and haemodynamic changes that can be of significance when combined with anaesthesia adminsterd during liver transplantation. The aim to assess the impact of intra-operative and post-operative Terlipressin infusion in respect to Haemodynamic and renal parameters.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Digestive System,End-stage liver disease going for liver transplantation,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/08/2013
Actual trial start date 01/08/2013
Anticipated date of last follow up 31/08/2014
Actual Last follow-up date 31/08/2014
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants) 50
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 was variable) Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Terlipressin 1-4 mic/kg/hr Operation till 4 days postoperative Terlipressin infusion started at beginning of surgery (1.0 ¿g/kg / hr), the rate later titrated (1.0 ¿ 4.0 ¿g/kg / hr) to maintain a MAP > 65 mmHg and SVRI < 2600 dyne·s/cm5 / m2 till day 4. 25
Control Group Control saline infusion at the beginning of operation till day 4 25 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Model for end stage liver disease (MELD) between 12 and 20. Systemic vascular resistance index (SVRI) ¿ 1700 dyne·s/cm5/m2 History of myocardial infarction. Evidence of cardiac decompensation. Severe haemodynamic instability. Primary renal dysfunction. 18 Year(s) 55 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 01/07/2013 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 renal fuction 4 days postoperative
Secondary Outcome catacholamine support intraoperative
Secondary Outcome systemic vascular resistance intraoperative
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 Hospital
COLLABORATORS
Name Street address City Postal code Country
Nagwa Ibrahim Mowafy Berket el sabaa Al Menoufiya Egypt
Mohamed Helmy Afifi Tanta Al gharbia Egypt
Magdy khalil Tanta Al gharbia Egypt
Khaled Ahmed Yassen Yassin abd elghafar street SHEBIN el kom Egypt
Ashraf Salah El Deen Hasanen Shebin el kom Al Menoufiya Egypt
Sabry Ibrahim Abd Allah Menof Al Menoufiya Egypt
Eman Sayed Ibrahim Yassin abd elghafar street SHEBIN el kom Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Khaled Yassen kyassen61@hotmail.com 002-01063080170 Yassin abd elghafar street
City Postal code Country Position/Affiliation
SHEBIN el kom Egypt Professor of Anaesthesia
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 Nagwa Mowafy nagwaibraheem85@yahoo.com 002-01002773431 Yassin abd elghafar street
City Postal code Country Position/Affiliation
SHEBIN el kom Egypt Doctor of Anaesthesia
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