Investigating the preventive effect of taurine on the incidence of reperfusion syndrome in liver transplant recipients
Design
A double-blind clinical trial that includes 100 liver transplant candidates. A permutation block randomization method will be used to divide patients into two groups.
Settings and conduct
In this study, randomization is done using a table of random numbers, and in a ratio of one to one to one of the groups, taurine 2 grams in one place half an hour before the start of surgery and another group placebo 2 grams of carboxymethyl cellulose half an hour before the start of surgery. It is given and all the information of the patients during and after the operation is recorded and analyzed after collection. This study will be conducted in Bouali Hospital affiliated to Shiraz University of Medical Sciences, Shiraz, Iran.
Participants/Inclusion and exclusion criteria
All adult patients over 18 years of age who undergo liver transplantation are admitted to the organ transplant hospital Bu Ali Sina Shiraz is located. Re-transplantation or simultaneous liver and kidney transplantation as well as known sensitivity to taurine are among the exclusion criteria. For all patients, the method of performing the plan, its advantages and disadvantages are explained before anesthesia, and if the patient agrees, he is included in the study.
Intervention groups
Patients are randomly divided into two groups: one group is given 2 grams of taurine half an hour before surgery, and the other group is given 2 grams of placebo (carboxymethyl cellulose) half an hour before surgery.
Main outcome variables
Main outcomes: information after liver transplantation including length of stay in ICU and hospital, need for dialysis or CRRT after liver transplantation, functional status of the transplanted organ during hospitalization and also patient death.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120731010453N3
Registration date:2023-03-14, 1401/12/23
Registration timing:prospective
Last update:2023-03-14, 1401/12/23
Update count:0
Registration date
2023-03-14, 1401/12/23
Registrant information
Name
Mojtaba Shafiekhani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3242 4255
Email address
mshafikhan@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-25, 1402/01/05
Expected recruitment end date
2023-12-13, 1402/09/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The protective Effect of taurine on Ischemia-reperfusion syndrom Following liver transplantation
Public title
Preventive effect of taurine drug on liver transplant recipients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
All patients which candidate to liver transplant older than 18 years old
Exclusion criteria:
Re-transplantation or simultaneous liver and kidney transplantation
Hypersensitivity to taurine
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
All patients are randomly divided into two groups receiving taurine supplement or placebo according to the permuted block randomization method.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants, transplant surgeon; transplant anesthesiologist and clinical pharmacist are completely blind to the type of intervention.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Central building of Shiraz University of Medical Sciences Zand St., Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
71348-14336
Approval date
2023-02-08, 1401/11/19
Ethics committee reference number
IR.SUMS.REC.1401.659
Health conditions studied
1
Description of health condition studied
liver transplantation
ICD-10 code
T86.49
ICD-10 code description
Other complications of liver transplant
Primary outcomes
1
Description
Occurrence of reperfusion syndrome during the surgery
Timepoint
During the surgery
Method of measurement
By reviewing patient information
2
Description
The required dose of norepinephrine during surgery in order to correct the hypotension
Timepoint
During the surgery
Method of measurement
By reviewing patient information
Secondary outcomes
1
Description
The functional state of the organ from the time of transplantation to the time of discharge
Timepoint
Duration of hospitalization
Method of measurement
By reviewing patient file information
2
Description
Duration of hospitalization in the ICU hospital for CRRT or dialysis
Timepoint
Duration of hospitalization
Method of measurement
By reviewing patient file information
3
Description
Mortality rate
Timepoint
Duration of hospitalization
Method of measurement
By reviewing patient file information
4
Description
Need for CRRT or dialysis during hospitalization
Timepoint
Duration of hospitalization
Method of measurement
By reviewing patient file information
Intervention groups
1
Description
Intervention group: One group is given 2 grams of taurine half an hour before surgery.
Category
Prevention
2
Description
Control group: Placebo 2 grams of carboxymethyl cellulose is given half an hour before surgery
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Abu Ali Sina Organ Transplant hospital
Full name of responsible person
Mojtaba Shafiekhani
Street address
Abu Ali Sina Organ Transplant, Sadra Highway
City
Shiraz
Province
Fars
Postal code
71994-67985
Phone
+98 71 3344 0000
Email
mojtabashafiekhani@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
mohammad mehdi hashempour
Street address
Central building of Shiraz University of Medical Sciences Zand St
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3212 2713
Email
relation@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mojtaba Shafiekhani
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
School of Pharmacy, Karafrin street, Roknabad, Shiraz
City
Erlangen
Province
Fars
Postal code
71546-57145
Phone
+98 71 3242 4255
Fax
+98 71 1242 4126
Email
mojtabashafiekhani@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mojtaba Shafiekhani
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
School of Pharmacy, Karafrin street, Roknabad, Shiraz
City
shiraz
Province
Fars
Postal code
71546-57145
Phone
+98 71 3242 4255
Email
mshafikhan@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mojtaba Shafiekhani
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
School of Pharmacy, Karafrin street, Roknabad, Shiraz
City
shiraz
Province
Fars
Postal code
71546-57145
Phone
+98 71 3242 4255
Fax
+98 71 1242 4126
Email
mshafikhan@sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available