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.: PACTR201808140151322 Date of Approval: 13/08/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Oesophageal Doppler compared to Plethysmographic Variability Index to Guide Perioperative Fluid Management for Cirrhotic Patients undergoing Liver Resection
Official scientific title Oesophageal Doppler compared to Plethysmographic Variability Index to Guide Perioperative Fluid Management for Cirrhotic Patients undergoing Liver Resection: A randomized controlled study
Brief summary describing the background and objectives of the trial Fluid therapy during hepatic surgery has to be balanced so as to ensure adequate tissue perfusion and cellular oxygenation while avoiding fluid overload and hepatic congestion, which can lead to difficult dissection and potentially excessive bleeding. Fluid restriction by targeting a low CVP has been recommended for liver resections. Low CVP (below 5 mmHg) has been associated with decreased blood loss. There is also an increased risk of postoperative renal injury. On the other hand, excessive fluid administration results in difficult liver dissection and excessive bleeding as well as subsequent risk of fluid overload. Following hepatic resection, rehydration to a euvolemic state is utilized to ensure adequate perfusion to vital organs. According to the recommendations of the enhanced recovery after surgery( ERAS) working group, fluid overload prevention is important. Surgical access to posterior liver tumours may involve transient compression of the inferior vena cava, which can cause profound hypotension. Fluid transfusion will maintain blood pressure during these episodes but will also elevate CVP and promote bleeding. The best management of this situation involves cautious fluid transfusion and close communication with the surgical team. Positive end expiratory pressure not only reduces lung atelectasis but also elevates CVP and reduces liver blood flow, so should be avoided during the resection process. Transesophageal Doppler (TED) is a minimal invasive bedside monitor that can allow the continuous monitoring of several hemodynamic variables, with this technique a pulsed, competitive-frequency continuous-wave Doppler signal is emitted from a probe placed in the distal esophagus and directed at the descending thoracic aorta. • The primary aim is to investigate the Plethysmographic Variability Index compared to parameters obtained from transesophageal doppler for monitoring and management of fluid guided management during and after liver resection and
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Digestive System
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 01/09/2018
Actual trial start date 01/09/2018
Anticipated date of last follow up 01/09/2019
Actual Last follow-up date 01/09/2019
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 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 TED Whole operation time Boluses of colloid will be administered, guided by an algorithm depending on the Doppler estimations of Stroke volume (SV) and Corrected flow time (FTc) 20
Control Group PVI Whole operation time Boluses of colloid will be administered, guided by an algorithm depending on PVI. 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Child classification A and B Scheduled for liver resection. Child classification C Patients with any cardiac lesion. 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). Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 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 01/08/2018 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 Amount of blood transfused Intraoperative and postoperative ICU stay
Secondary Outcome Amount of crystalloid fluid transfused Intraoperative and postoperative ICU stay
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
Ashraf Mohamed Mostafa 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
Hanaa Said Abdelhafez Yassin Abdel Ghaffar Street from Gamal Abdel Anasar Street Shebin elkom 32511 Egypt
Fatima Farouk Mohamed Adham ElSahn Yassin Abdel Ghaffar Street from Gamal Abdel Anasar Street Shebin elkom 32511 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator 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
Scientific Enquiries Ashraf Moussa ashrafmoussa91@hotmail.com 00201227317050 Yassin Abdel Ghaffar Street from Gamal Abdel Anasar Street
City Postal code Country Position/Affiliation
Shebin elkom 32511 Egypt Professor of Anaesthesia Intensive Care and Pain Management Faculty of Medicine Menoufiya 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