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.: PACTR202404838380059 Date of Registration: 25/04/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The Protective Role of Dexmedetomidine on Hepatic Injury of the Donor of Liver Transplant
Official scientific title The Protective Role of Dexmedetomidine on Hepatic Injury of the Donor of Liver Transplant: A Randomised Control Trial: A Randomised Control Trial
Brief summary describing the background and objectives of the trial Living donor liver transplantation (LDLT) is a successful treatment for patients with end-stage liver disease; this procedure is possible because of the segmental structure of the liver and the regeneration potential of the remnant partsIt is well known that a large enough residual healthy liver volume should remain in the donors to meet metabolic demand until the remnant regenerates to a sufficient size. Although, the remnant liver can be affected by direct surgical dissection and dividing blood supply or indirectly via inflammatory processes activated by them.The objective is to study the protective role of dexmedetomidine (DEX) on the hepatic injury of the donor liver transplant by investigating the inflammatory markers
Type of trial RCT
Acronym (If the trial has an acronym then please provide) LT.DEX
Disease(s) or condition(s) being studied Anaesthesia
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/02/2024
Actual trial start date 01/02/2024
Anticipated date of last follow up 01/02/2025
Actual Last follow-up date
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL IN anasthesia and analgesia journals and pain manegement journals
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 Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group control group infusion of 0.5 ug/kg/hr of normal saline prepared as 50 ml 0.9 % saline from patient arrival to preparation room till the last suture infusion of 0.5 ug/kg/hr of normal saline prepared as 50 ml 0.9 % saline in 20G peripheral cannula from patient arrival to preparation room till the last suture 25 Placebo
Experimental Group dex group 0.5 ug/kg/hr of DEX prepared as 200 ug ampule in 50 ml 0.9 % saline from patient arrival to preparation room till the last suture continuous maintenance infusion of 0.5 ug/kg/hr of DEX prepared as 200 ug ampule in 50 ml 0.9 % saline in 20G peripheral cannula from patient arrival to preparation room till the last suture 25
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Donors aged ≥ 18 to ≤ 45 years. - Both sexes. - Classified by American Society of Anesthesiologists (ASA) I and II who will be candidates to be donors of ALDLT. - A patient refused to participate in the study. - Allergy to any of the study drugs by history. - A body-mass index higher than 35 kg/m². - Those on hypnotics or antidepressant drugs. 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 01/01/2024 institutional review board
Ethics Committee Address
Street address City Postal code Country
yaseen abdelghafar shebeen elkoom 23456 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome the level of human tumor necrosis factor-α (TNF-α) by enzyme-linked immunosorbent assay (ELISA) test. preoperative and postoperative day one
Secondary Outcome • Liver profile: alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin (TBIL) and international normalized ratio (INR). • Hemodynamic stability (heart rate, mean arterial blood pressure, and cardiac output by Electrical Cardiometry). • Opioid requirements. preoperative, intraoperative and postoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
NAtional liver institute yassen abdelghafa street shebeen elkom 23456 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
national liver institute yaseen abdelghafar shebeen elkom 23456 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor natioanl liver institute yassen abdelghafar shebeen elkoom 23456 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator mohamed Youssef drmhmdtarek90@gmail.com 0248986754 yaseen abdelghafar
City Postal code Country Position/Affiliation
shebeen elkoom 23456 Egypt assisstent lecture of anasthesia
Role Name Email Phone Street address
Public Enquiries hanaa rashed hanaarashed2020@yahoo.com 0248986754 yaseen abdelghafar
City Postal code Country Position/Affiliation
shebeen elkoom 23456 Egypt lecturer of anasthesia
Role Name Email Phone Street address
Scientific Enquiries mohamed Youssef drmhmdtarek90@gmail.com 0248986754 yaseen abdelghafar
City Postal code Country Position/Affiliation
shebeen elkoom 23456 Egypt assisstent lecture of anasthesia
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes we intend sharing study protocol , aim of the work, patient and method and the results when be available.sharing of de-identified individual trial participant data. Informed Consent Form,Study Protocol when the data available will be shared by searching The Protective Role of Dexmedetomidine on Hepatic Injury of the Donor of Liver Transplant:
URL Results Available Results Summary Result Posting Date First Journal Publication Date
international anasthesia and analgesia journal 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