Determination of the effect of taurine in improvement of liver function in patients receiving liver transplantation in Shiraz as a double-blinded clinical trial
Design
Randomized controlled clinical trial, parallel groups, double blind, phase 3, on 102 patients. For randomization, random number table was used.
Settings and conduct
In our study, participants and investigator don't know that each patient has received which of the taurine or placebo.
Participants/Inclusion and exclusion criteria
Inclusion criteria before randomization: Age older than 18 years, hospitalization for at least 1 week and filling informed consent.
Exclusion criteria before randomization: allergy to taurine, lack of consent, pregnancy and lactation, simultaneous liver and kidney transplantation, parenteral nutrition containing parenteral amino acids, heart failure and lithium.
Intervention groups
patients will be divided randomly into two groups of receiving: taurine (500 milligrams twice a day) or placebo (carboxy methyl cellulose) (500 milligrams twice a day) for 1 month.
Main outcome variables
Improvement of the transplanted liver function regarding hepatic enzymes;
Prevention of acute rejection of the transplanted organ;
Rate of new-onset diabetes after transplantation;
Rate of delirium development.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200312046755N1
Registration date:2020-07-18, 1399/04/28
Registration timing:prospective
Last update:2020-07-18, 1399/04/28
Update count:0
Registration date
2020-07-18, 1399/04/28
Registrant information
Name
Shaghayegh Mottaghi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3242 5374
Email address
motaghish@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-22, 1399/06/01
Expected recruitment end date
2021-03-10, 1399/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of taurine on graft function in post-liver transplant recipients, a double-blind clinical trial
Public title
Effect of taurine in liver transplantation
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
All the patients older than 18 who are candidates for liver transplantation in Abu-Ali Sina hospital of Shiraz
Hospitalization for at least 1 week after liver transplantation in Abu-Ali Sina hospital of Shiraz
Filling the inclusion consent form by the patient
Exclusion criteria:
Allergy to taurine
Lack of consent
Pregnancy and lactation
Simultaneous liver and kidney transplantation
Parenteral nutrition containing parenteral amino acids,
Heart failure
Lithium
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
102
Randomization (investigator's opinion)
Randomized
Randomization description
After liver transplantation surgery, using random number table, all qualified patients were divided to the two groups of intervention and control. This table is provided by bio-statistics specialist and patients are divided into one of the two groups in order of sampling to receive taurine or placebo randomly.
Blinding (investigator's opinion)
Double blinded
Blinding description
In our study, participants (patients) and researcher don't know that each patient has received which of the taurine or placebo. Taurine and placebo, both are provided in 500-milligram capsules with the same shape, color and size and in the same packaging and just one of the co-workers, who doesn't have any role in evaluation of outcomes and analyzing the data, knows about division of patients based on random number table.
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
Zand ave., Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
71348-14336
Approval date
2020-06-06, 1399/03/17
Ethics committee reference number
IR.SUMS.REC.1399.349
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
Improvement of the transplanted liver function regarding hepatic enzymes
Timepoint
Within the first month after transplantation
Method of measurement
Via studying the patient's file's data
2
Description
Prevention of acute rejection of the transplanted organ
Timepoint
Within the first month after transplantation
Method of measurement
Diagnosis and confirmation by the related physician
Secondary outcomes
1
Description
Rate of new-onset diabetes after transplantation
Timepoint
Within the first month after transplantation
Method of measurement
Laboratory data related to serum glucose and HbA1C
2
Description
Rate of delirium development
Timepoint
Within the first month after transplantation
Method of measurement
CAM-ICU score
Intervention groups
1
Description
Intervention group: Patients will receive taurine (from Purebulk Inc.) in amount of two 500-milligram capsules twice a day (equal to 2 grams per day) for 30 days.
Category
Treatment - Drugs
2
Description
Control group: Patients will receive carboxy methyl cellulose (from Merck company) as placebo in amount of two 500-milligram capsules twice a day (equal to 2 grams per day) for 30 days.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Abu-Ali-Sina organ transplantation hospital
Full name of responsible person
Shaghayegh Mottaghi
Street address
No.958, Pasdaran Blvd., Boostan Blvd., Sadra City, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
7199467985
Phone
+98 71 3344 0000
Fax
+98 71 3643 0038
Email
abualisinacharity@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Younes Ghasemi
Street address
Zand ave., Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3230 5410
Fax
Email
info@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
Shaghayegh Mottaghi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Karafarin st., Roknabad
City
Shiraz
Province
Fars
Postal code
7146864685
Phone
+98 71 3242 4127
Email
shaghayeghm_70@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Shaghayegh Mottaghi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Karafarin st., Rokn Abad, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
7146864685
Phone
+98 71 3242 4127
Email
shaghayeghm_70@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Shaghayegh Mottaghi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Karafarin st., Roknabad, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
7146864685
Phone
+98 71 3242 4127
Email
shaghyeghm_70@yahoo.com
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
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be 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
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available