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.: PACTR201902855547795 Date of Approval: 05/02/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Plethysmography Variability Index and Stroke Volume Variation Changes in Relation to Central Venous Pressure Changes during Live Donor Right Hepatotomy
Official scientific title Plethysmography Variability Index and Stroke Volume Variation Changes in Relation to Central Venous Pressure Changes during Live Donor Right Hepatotomy
Brief summary describing the background and objectives of the trial Living donor liver transplantation from healthy volunteers is the only available treatment for patients with end stage liver disease in every transplant center in Egypt as cadaveric donation still remains unavailable in this part of the world. The low central venous pressure (CVP) protocol usually adopted to reduce blood loss during the process of dissection of the liver requires the insertion of a central venous catheter as an invasive monitor tool. Improving monitoring to be less or non-invasive methods will help to reduce risks and improve donor safety, CVP monitoring role in reducing blood loss is been questioned. In centers with extensive experience, CVP monitoring may not be necessary in this highly selective patient population. The importance of donor safety during hepatotomy is widely recognized, and the potential risks during the perioperative period are a major concern. Donor hepatotomy is definitely not a complication‑free procedure; reported complication risks should be available to the volunteers during consenting and every effort to reduce risks should be encouraged. The primary aim of this work Is to investigate the changes in plethysmography variability index and stroke volume variation in a group of donors in relation with central venous pressure changes during the various stages of liver resection (Right Hepatotomy) in healthy volunteers and find the ranges of agreement between PVI and SVV to similar ranges of CVP.
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 Diagnosis / Prognosis
Anticipated trial start date 15/04/2017
Actual trial start date 15/04/2017
Anticipated date of last follow up 01/12/2018
Actual Last follow-up date 01/12/2018
Anticipated target sample size (number of participants) 34
Actual target sample size (number of participants) 34
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 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 PVI From induction of anaestehsia till end of surgery Pleth variability Index was measured with a pulse oximetry. (Massimo set version, Massimo co., Irvin, California, USA) by placing the probe on the finger of the donor. 17
Control Group CVP From induction of anaestehsia till end of surgery A 7 French triple lumen central venous catheter was inserted, ultrasound guided, in the right internal jugular vein, the catheter was connected to a pressure transducer, the pressure trace was displayed continuously. 17 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Adult volunteers scheduled for right hepatotomy for live liver transplantation. ASA classification I or II. Normal liver function test renal function test and serum electrolytes Perioperative cardiovascular or hemodynamic disease. Presence of coagulation disorder. Positive end-expiratory pressure (PEEP) application, pulmonary disease, tricuspid valve disease, pericardial effusion, increased intra-abdominal pressure as with laparocopic liver resection surgery Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 45 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 01/12/2018 IRB National Liver Institute
Ethics Committee Address
Street address City Postal code Country
Yassen abd elghafar street Shebin Elkom 32511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Complications of invasive CVP (e.g. pneumothorax) From the start of induction till 24 hours postoperatively
Secondary Outcome Need for fluid management From the start of induction till 24 hours postoperatively
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
National liver institute Yassen abd elghafar Shbin Elkom 32511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Omnia gamal ibrahim baiomy Yassen abd Elgaffar Shebin Elkom 32511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor National liver institute Yassen abd Elgaffar Shebin Elkom 32511 Egypt University
COLLABORATORS
Name Street address City Postal code Country
MamdouhElsayed lofty Yassen abd Elgaffar Shebin Elkom 32511 Egypt
Khaled Ahmed Yassen Yassen abd Elgaffar Shebin Elkom 32511 Egypt
Amany said ammar Yassen abd Elgaffar Shebin Elkom 32511 Egypt
Yasmin AbdElsalam Kamel Yassen abd Elgaffar Shebin Elkom 32511 Egypt
Omnia gamal ibrahim baiomy Yassen abd Elgaffar Shebin Elkom 32511 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mamdouh Lotfy mamdouhlotfy77@yahoo.com 00201222181710 Yassen abd Elgaffar
City Postal code Country Position/Affiliation
Shebin Elkom 32511 Egypt Professor of Anaesthesia Intensive care pain management Faculty of Medicine Menoufia University
Role Name Email Phone Street address
Scientific Enquiries khaled yassen Kyassen61@hotmail.com 00201063080170 Yassen abd Elgaffar
City Postal code Country Position/Affiliation
Shebin Elkom 32511 Egypt Professor of Anaesthesia and Intensive Care and Head of Anaesthesiology Department National Liver Institute Menoufia 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
No
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