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.: PACTR201604001588289 Date of Approval: 15/04/2016
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Perioperative Guided Fluid Management with Electrical Cardiometry versus Central Venous Pressure for Liver Resection in Cirrhotic Patients
Official scientific title Perioperative Guided Fluid Management with Electrical Cardiometry versus Central Venous Pressure for Liver Resection in Cirrhotic Patients
Brief summary describing the background and objectives of the trial The study will use a new non invasive device versus the standard monitoring mechanism for continuous monitoring and fluid administration to cirrhotic patients undergoing major liver resection. The primary aim is to investigate the electrical cardiometry parameters compared to parameters obtained from central venous catheterization and the standard monitoring for fluid guided management during and after liver resection. The secondary aim of the work is to study Haemodynamic changes associating liver resection in cirrhotic patients during the immediate perioperative period with both standard monitoring and electric cardiometry. Effect of adopting each method for monitoring and management on the perioperative haemodynamic therapy, postoperative complications, intensive care unit stay and outcome. Practical use of the electric cardiometry during major surgery and the advantages and disadvantages associating its use, and if cardiometry can modify or replace the standard monitoring method.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Digestive System,Liver cirrhosis,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 01/03/2016
Actual trial start date 20/04/2016
Anticipated date of last follow up 31/03/2017
Actual Last follow-up date 31/03/2017
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 randomisation (block size was variable minimum of 4) Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Cardiometry perioperative The four electric cardiometry electrodes will be applied after skin sterilization by alcohol swab. Two electrodes will be placed vertically on the left side of the neck, while the other two will be placed on the left side of the thorax in the mid-axillary line. 20
Experimental Group CVP perioperative A 7 French triple lumen central venous catheter will be inserted, sonar guided, in the right internal jugular vein, the catheter will be connected to a pressure transducer, the pressure trace will be displayed continuously and will be recorded every 15 min 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
ASA classification I-II. Child classification A. Modified Moemen score (7-8). Model for End-Stage Liver Disease (MELD) score<10. Scheduled for liver resection. Any patient with perioperative cardiovascular or hemodynamic instability. Presence of severe coagulation disorder. The use of oral anticoagulants, other anti-thrombotic drugs or any drug which affects coagulation profile. Extra hepatic malignancy. Patients with any cardiac lesion. Major intraoperative events. (e.g. air embolism, severe hemorrhage) 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 19/01/2017 National Liver Institute IRB
Ethics Committee Address
Street address City Postal code Country
Yaseen abdelghafar Alexandria 32513 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome ¿ Efficient fluid guided management during and after liver resection. ALL OVER THE SURGERY AND POSTOPERATIVE
Secondary Outcome Postoperative complications Postoperative period
Secondary Outcome intensive care unit stay postoperative in the ICU
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
National Liver Institute Yassin abdolghafar Shebin elkoom 32513 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
National Liver Institute Yassin abdolghafar Shebin elkoom 32513 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor National Liver Institute Yassin abdolghafar Shebin elkoom 32513 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Ahmed Mansour Abdou El Azerita Square Alexandria 21516 Egypt
Khaled Ahmed Yassen Yassin abdolghafar Shebin elkoom 32513 Egypt
Tarek Atef Tawfik El Azerita Square Alexandria 21516 Egypt
Maha Lotfy EL Sheikh Yassin abdolghafar Shebin elkoom 32513 Egypt
Riham Ali Hussein Ali El Azerita Square Alexandria 21516 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed Mansour AhmedMansour@yahoo.com 002-0100-2333413 El Azerita Square
City Postal code Country Position/Affiliation
Alexandria 21516 Egypt Professor of Anaesthesia and Surgical 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 Khaled Yassen kyassen61@hotmail.com 002-010-63080170 Yassin Abdelghaffar
City Postal code Country Position/Affiliation
Shebin El Kom 32513 Egypt Professor of Anaesthesia and Liver Intensive care
REPORTING
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