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.: PACTR201811462663708 Date of Approval: 26/11/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The Respiratory and Hemodynamic Effects of Alveolar Recruitment during and after Liver Transplantation: RCT
Official scientific title The Respiratory and Hemodynamic Effects of Alveolar Recruitment during and after Liver Transplantation: A Randomized Controlled Study
Brief summary describing the background and objectives of the trial Anesthesiologists help in managing the perioperative period for recipient of liver transplant with its different ventilatory impairments which affect the clinical outcomes. Lung injury after Liver transplantation can present as a serious complication, associated with diffuse, bilateral pulmonary infiltrates. This injury could demand a prolonged endotracheal intubation and a lengthy intensive care unit stay (ICU) with increased risk of exposure to infection. Lung recruitment together with the optimal PEEP may help those patients. Recruitment aims to re-expand any collapsed lung tissue, and maintain this re-expansion with an optimal positive end expiratory pressure (PEEP) to prevent subsequent de-recruitment. Optimal PEEP helps to maximize the arterial oxygenation while maintaining adequate oxygen transport and perfusion of the tissues.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Digestive System,End stage liver disease
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/10/2017
Actual trial start date 15/10/2017
Anticipated date of last follow up 31/10/2018
Actual Last follow-up date 31/10/2018
Anticipated target sample size (number of participants) 57
Actual target sample size (number of participants) 57
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 Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Alveolar recruitment maneuvre ARM Intraoperative and postoperative till extubation Increase Inspiratory Pressure and positive end expiratory pressure every 2 respiratory cycles until a peak 35cmH2O and a PEEP of 20cmH2O is reached, followed by a reduction of the pressures until optimal PEEP is reached . The cycle will be repeated until reaching the known optimal PEEP 28
Control Group Control Intraoperative and postoperative till extubation No Alveolar recruitment maneuvre was used 29 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Model of end stage liver disease (MELD) score less than 24. Elective adult living donor liver transplant recipient patients with chronic liver disease. -Patients with pre-existing significant pulmonary disease with abnormalities in spirometry, previous lung surgery, home oxygen therapy and significant cardiac dysfunction. -Acute liver failure and redo-transplant. -Patients with pulmonary hypertension. -Body-mass index higher than 40 kg/m² -Unwilling to participate in the study. 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 07/10/2017 IRB National Liver Institue 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 Arterial oxygen tension (PaO2) After induction after recruitment after placement of retractor anhepatic reperfusion ICU after extubation
Primary Outcome The ratio of PaO2 to the fraction inspired oxygen (PaO2/FIO2) After induction after recruitment after placement of retractor anhepatic reperfusion ICU after extubation
Secondary Outcome incidence of postoperative pulmonary complications (pleural effusion –pneumonia-respiratory failure) in the intensive care unit for the first 5 days
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
Khaled Ahmed Yassen Yassin Abdel Ghaffar Street from Gamal Abdel Anasar Street Shebin elkom 32511 Egypt
Ahmed AbdelRaouf Metwally Yassin Abdel Ghaffar Street from Gamal Abdel Anasar Street Shebin elkom 32511 Egypt
Naglaa Moustafa Hussain Yassin Abdel Ghaffar Street from Gamal Abdel Anasar Street Shebin elkom 32511 Egypt
Menna Allah Aly ElShafie 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 Naglaa Hussain naglaa_ysh@yahoo.com 00201142222832 Yassin Abdel Ghaffar Street from Gamal Abdel Anasar Street
City Postal code Country Position/Affiliation
Shebin elkom 32511 Egypt Lecturer of Anesthesiology and Intensive Care 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