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.: PACTR201402000776978 Date of Approval: 21/02/2014
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title continuous infusion of dexamedetomedine on gas calarimetry monitoring in liver transplantation
Official scientific title Effect of continuous infusion of dexamedetomedine on perioperaive indirect gas calarimetry monitoring in liver transplantation.
Brief summary describing the background and objectives of the trial Dexamedetomidineis able to decrease oxygen consumption in the intraoperative period (up to 8%) and in the postoperative period (up to 17%) in patients undergoing plastic surgery procedures under general anaesthesia in liver transplantation : Oxygen consumption decreased rapidly by 25% when the blood supply to the native liver was interrupted.,and there was a sharp increase of oxygen consumption with successful reperfusion of the allograft Carbon dioxide production fell by 14% and returned to preanhepatic values after successful declamping .It has been previously shown that the increase in whole body oxygen consumption occurs after reperfusion which may reflect oxygen uptake by the graft. Here we aaim to study effect of continuous infusion of dexamedetomedine on perioperaive indirect gas calorimetry monitoring on resipient of adult living donor liver transplantation (ALDLT)in liver transplantation.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Digestive System,Patients undergoing liver transplantation,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 15/06/2013
Actual trial start date 15/06/2013
Anticipated date of last follow up 15/05/2014
Actual Last follow-up date 15/05/2014
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 =4) and the block size was not 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 Dexmedetomedine 0.2-0.7 mic/kg/h Until extubation 30
Control Group Control 30 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All adult living donor liver transplantation Hemodynamic instability Respiratory instability: pulse oxygen saturation <90%, ,, and signs of hyperventilation (respiratory rate > 35/min) or respiratory weakness during pressure-support ventilation. High level of inspired oxygen required an FiO2 > 80% to obtain a pulse oxygen saturation > 90% . Patients in Hypermetabolic states.,diabetic ketoacidosis,andrenal failure(need high bicarb load) Patients on high carbohydrate load 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 01/06/2013 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 VO2,DCO2,EE,RQ (baseline) (A). anhepatic phase) (B). 30 minutes after reperfusion neohepatic phase(C). 60 min after reperfusion (D). at the end of operation (E). Before extubation
Secondary Outcome Haemodynamics ,icu stay ,post operative liver lab. haemodynamics correspoding to A,B¿ liver lab in 1st,3d,5th day.
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
Mohamed Helmy Afifi Yassin abd elghafar street SHEBIN el kom Egypt
Magdy khalil Yassin abd elghafar street SHEBIN el kom Egypt
Khaled Ahmed Yassen Yassin abd elghafar street SHEBIN el kom Egypt
Essam ismael LISCO Company Village Kasr Ahmed SHEBIN el kom Egypt
Nirmeen fayed Yassin abd elghafar street SHEBIN el kom Egypt
Nahla GabAlla 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 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 Magdy khalil Magdy_khalil20@yahoo.com 002-01001466228 Yassin abd elghafar street
City Postal code Country Position/Affiliation
SHEBIN el kom Egypt Professor of Anesthesia and Intensive Care Dean of National Liver Institute
REPORTING
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