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.: PACTR201807337809744 Date of Approval: 31/07/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Transjugular intrahepatic portosystemic shunt insertion in hepatic patients on the haemodynamics
Official scientific title Effect of transjugular intrahepatic portosystemic shunt insertion in hepatic patients on the haemodynamics
Brief summary describing the background and objectives of the trial Transjugular intrahepatic portosystemic shunt (TIPSS) is indicated for patients with cirrhosis complicated by refractory bleeding varices and refractory ascites. TIPS is considered a definitive treatment of portal hypertension caused by cirrhosis. On the successful insertion of the shunt a dramatic reduction in portal pressure is expected and this will effectively help in the management of recurrent variceal haemorrhage and refractory ascites. Portal decompression, through TIPS leads to introduction into the systemic circulation of further blood volumes from the congested portal circulation this is expected to lead to a further increase in cardiac output and vasodilatation to accommodate this acute increase, the ability of patients to respond will vary according to each patient general status and cardiac functions. Monitoring these acute changes can help to early diagnose dysfunctions and support the circulation when required. The primary aim is to investigate the changes in systemic and portal circulations and identify the haemodynamic changes associating the insertion of TIPS. secondary aim is to identify the ability to predict cut off values of measured parameters to help identify patients at risk prior to the shunt insertion also to Investigate the practicality of electric cardiometry to diagnose and manage these expected changes and finally to report the outcome of TIPS (morbidity and /or mortality) and success rate of insertion.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Digestive System
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 15/08/2018
Actual trial start date 15/08/2018
Anticipated date of last follow up 15/08/2019
Actual Last follow-up date 15/08/2019
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants) 40
Recruitment status Not yet 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 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 cardiometry Perioperative period four electric cardiometry skin sensors are applied, 6 parameters will be recorded at different time throughout the operation. 20
Control Group Central veous pressure and portal vein pressure Intraoperative A catheter is inserted in internal jugular vein and 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Adult patients scheduled for elective TIPS procedure with stable haemodynamic condition and acceptable echocardiography. Cardiac co-morbidity. Severe coagulation disorder. Renal failure. Neoplastic disease. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 65 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 25/12/2018 IRB Faculty of Medicine Menofyia University
Ethics Committee Address
Street address City Postal code Country
Yassin Abdel Ghaffar Street from Gamal Abdel Anasar Street Shebin elkom 32511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Cardiac output Before induction of sedation 5 minutes after induction of sedation 30 minutes after sedation 10 minutes after TIPS insertion 1 and 24 hours after TIPS insertion
Primary Outcome Systemic vascular resistant Before induction of sedation 5 minutes after induction of sedation 30 minutes after sedation 10 minutes after TIPS insertion 1 and 24 hours after TIPS insertion
Secondary Outcome Postoperative ICU length of stay postoperative period
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
National liver institute Yassin Abdel Ghaffar Street from Gamal Abdel Anasar Street Shebin elkom 32511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor National Liver Institute Yassin Abdel Ghaffar Street from Gamal Abdel Anasar Street Shebin elkom 32511 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mamdouh Lotfy El Sayed Yassin Abdel Ghaffar Street from Gamal Abdel Anasar Street Shebin elkom 32511 Egypt
Khaled Ahmed Yassen Yassin Abdel Ghaffar Street from Gamal Abdel Anasar Street Shebin elkom 32511 Egypt
Yasser Ibrahim Fathi Yassin Abdel Ghaffar Street from Gamal Abdel Anasar Street Shebin elkom 32511 Egypt
Yasmin Abd Elsalam Kamel Yassin Abdel Ghaffar Street from Gamal Abdel Anasar Street Shebin elkom 32511 Egypt
Mahmoud Mohammed Mahmoud Elmoniar Yassin Abdel Ghaffar Street from Gamal Abdel Anasar Street Shebin elkom 32511 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mamdouh El Sayed Mahmoudelsayed@gmail.com 0020482317502 Yassin Abdel Ghaffar Street from Gamal Abdel Anasar Street
City Postal code Country Position/Affiliation
Shebin elkom 32511 Egypt Professor of Anaesthesia and Intensive Care National Liver Institute Menofyia University
Role Name Email Phone Street address
Scientific Enquiries Khaled Yassen kyassen61@hotmail.com 00201063080170 Yassin Abdel Ghaffar Street from Gamal Abdel Anasar Street
City Postal code Country Position/Affiliation
Shebin elkom 32511 Egypt Professor of Anaesthesia and Intensive Care National Liver Institute Menofyia University
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 21615 Egypt Patient Information Manager
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Undecided
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
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