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.: PACTR201701001990415 Date of Approval: 22/01/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparison of electrical velocimetry and transoesophageal Doppler for haemodynamic monitoring during living donor liver transplantation
Official scientific title Comparison of electrical velocimetry and transoesophageal Doppler for haemodynamic monitoring during living donor liver transplantation
Brief summary describing the background and objectives of the trial The primary aim of this study is to compare EV and TED as their ability to guide perioperative fluid management in recipients for living donor liver transplant. The secondary aim is to test the ability of both technique separately to guide perioperative haemodynamics management and refer their effects on postoperative complications and intensive care unit stay.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Recipients for living donor liver transplant,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/01/2016
Actual trial start date 01/01/2016
Anticipated date of last follow up 30/06/2017
Actual Last follow-up date
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 randomization (variable block size) 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 Electrical velocimetry group Boluses of 3 ml/kg colloid solution Boluses of 3 ml/kg colloid solution will be given when Stroke volume variation (SVV) rise above 10% (a sustained change during the previous five minutes) or in the case of positive response (cardiac index (CI) increase above 10%) to previous fluid challenge 20
Experimental Group Doppler group Boluses of colloid will be administered, guided by an algorithm depending on the Doppler estimations of Stroke volume (SV) and Corrected flow time (FTc). Boluses of colloid will be administered, guided by an algorithm depending on the Doppler estimations of Stroke volume (SV) and Corrected flow time (FTc). This algorithm was similar to that used by Sinclair, 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All patient undergoing living donor liver transplantation aged. - Contraindication for esophageal Doppler as (coarctation of the aorta, oesophageal stent, carcinoma of the oesophagus or pharynx, previous oesophageal surgery, oesophageal stricture, pharyngeal pouch, and severe coagulopathy). - History of myocardial infarction. - Evidence of cardiac decompensation. - Severe haemodynamic instability. 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 01/01/2016 National Liver Institute, IRB
Ethics Committee Address
Street address City Postal code Country
Yaseen abdelghafar Shebin elkoom 32513 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Fluid management Perioperative period
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
National Liver Institute Yaseen abdelghafar Shebin elkoom 32513 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
National Liver Institute Yaseen abdelghafar Shebin elkoom 32513 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor National Liver Institute Yaseen abdelghafar Shebin elkoom 32513 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Khaled Ahmed Yassen Yaseen abdelghafar Shebin elkoom 32513 Egypt
Nagwa Ibrahim Mowafy Berket el sabaa Al Menoufiya 31142 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator khalid yassen kyassen61@hotmail.com 002-01063080170 Yassin abdolghafar street
City Postal code Country Position/Affiliation
Shebin elkoom 32513 Egypt Professor and Head Anaesthesia and Liver 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 Nagwa Mowafy nagwaibraheem85@yahoo.com 002-01002773431 Yassin abdolghafar street
City Postal code Country Position/Affiliation
Shebin elkoom 32513 Egypt Assistant Lecture of Anaesthesia and Liver Intensive care
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information