The aim of this study is to evaluate the treatment with octreotide for 3 days in patients after Liver Transplantation. 60 patients will be enrolled and followed during 4 weeks. The effects on renal function will be evaluated 4 weeks after the beginning of the treatment by isotopic evidence and biochemist determinations.
Design
A Randomized, Double-Blind, Placebo-Controlled Trial
Settings and conduct
A Randomized, Double-Blind, Placebo-Controlled Trial
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
• Age between 18 and 60 years
• Cirrhosis of the liver defined by clinical, biochemical or histological
• That, properly informed, give their consent to participate in the study and undergo tests and examinations that entails
• Women of childbearing potential: pregnancy test negative serum or urine, and acceptance of use of adequate contraception since at least 14 days prior to the first dose of study drug until 14 days after the last dose
Exclusion Criteria:
• Pregnant women, nursing mothers, or those who intend to become pregnant during the study period
• Systolic blood pressure ≥ 150 mmHg and / or diastolic blood pressure ≥ 90 mmHg
• Previous treatment with transjugular intrahepatic portosystemic shunt (TIPS) or surgical portosystemic shunts
Intervention groups
Drug: Octreotide
Octreotide by IV injection 50 mcg per hours for 3 days.
Drug: Placebo
placebo by IV injection 50 mcg per hours for 3 days.
Main outcome variables
1. Glomerular filtration
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190619043942N1
Registration date:2021-12-09, 1400/09/18
Registration timing:retrospective
Last update:2021-12-09, 1400/09/18
Update count:0
Registration date
2021-12-09, 1400/09/18
Registrant information
Name
Hoda Safa Isini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3230 9615
Email address
hodasafa225@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-23, 1400/05/01
Expected recruitment end date
2021-08-23, 1400/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Impact of Octreotide on Renal Function of Patients after Liver Transplantation; A Randomized, Double-Blind, Placebo-Controlled Trial
Public title
Impact of Octreotide on Renal Function of Patients after Liver Transplantation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1.Age between 18 and 60 years 2.Cirrhosis of the liver defined by clinical, biochemical or histological That, properly informed, give their consent to participate in the study and undergo tests and examinations that entails Women of childbearing potential: pregnancy test negative serum or urine, and acceptance of use of adequate contraception since at least 14 days prior to the first dose of study drug until 14 days after the last dose
Exclusion criteria:
1.Pregnant women, nursing mothers, or those who intend to become pregnant during the study period 2.Systolic blood pressure ≥ 150 mmHg and / or diastolic blood pressure ≥ 90 mmHg 3.Previous treatment with transjugular intrahepatic portosystemic shunt (TIPS) or surgical portosystemic shunts 4.Simultaneous Liver, Kidney Transplant 5.Cardiac or respiratory failure 6.Positive for human immunodeficiency virus 7.Urinary retention 8.Ischemic heart disease or peripheral vascular disease 9.Narrow Angle Glaucoma 10.Cerebrovascular occlusions 11.Aortic Aneurysm 12.Thyrotoxicosis 13.Pheochromocytoma 14.Diabetes Melitus 15.History of Hemodialysis prior to Liver Transplant 16.PreTransplant Cr more than 2.5mg/dl
Age
From 18 years old to 80 years old
Gender
Both
Phase
4
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The patients were randomized into two groups at a ratio of 1:1 using random allocation software (RAS)(M. 2004).
The randomization codes remained concealed until all patients had completed their follow-up and the database had been verified and closed. There is no emergency case that required breaking the blind on randomization.
Blinding (investigator's opinion)
Double blinded
Blinding description
Allocation concealment:Numbered drug containers, Blinding description: This study is double blind. Researcher and clinical care giver who complete questionnaire and patients are blind
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 street
City
shiraz
Province
Fars
Postal code
71345-1978
Approval date
2021-08-10, 1400/05/19
Ethics committee reference number
IR.SUMS.MED.REC.1400.252
Health conditions studied
1
Description of health condition studied
Liver Transplantation
ICD-10 code
Z94.4
ICD-10 code description
Liver transplant status
Primary outcomes
1
Description
1. Glomerular filtration
Timepoint
3 Days after Intervention, 1week after Intervention, 4 weeks after Intervention
Method of measurement
Change in glomerular filtration rate measured by isotopic tests
Secondary outcomes
1
Description
Changes in renal function
Timepoint
3days, 1 week, 4 weeks after cessation of treatment
Method of measurement
Lab test
Intervention groups
1
Description
intervention group 1: octerotide 50 mg / h intravenous infusion for three days from one of the Domestic manufacturer factory that will be provided by Namazi Hospital Intervention
Category
Treatment - Drugs
2
Description
Control group: Placebo 50 mg / h intravenous infusion for three days from one of the domestic manufacturer factory, the same as octerotide
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Abualisina Hospital
Full name of responsible person
Kamran Bagheri Lankarani
Street address
zand street
City
shiraz
Province
Fars
Postal code
71937-11351
Phone
+98 71 3230 9615
Email
lankaran@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Vice Chancellor of Research Affairs of Shiraz University of Medical Sciences
Street address
zand street
City
shiraz
Province
Fars
Postal code
71937-11351
Phone
Email
lankaran@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
kamran bagheri lankarani
Position
Professor of internal medicine
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
zand street
City
shiraz
Province
Fars
Postal code
71937-11351
Phone
+98 71 3230 9615
Email
lankaran@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
kamran bagheri lankarani
Position
professor of internal medicine
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
zand street
City
shiraz
Province
Fars
Postal code
71937-11351
Phone
+98 71 3230 9615
Email
lankaran@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
hoda safa
Position
Gastroenterologist
Latest degree
Subspecialist
Other areas of specialty/work
Gastroenterology
Street address
zand street
City
shiraz
Province
Fars
Postal code
71937-11351
Phone
+98 71 3230 9615
Email
hodasafa225@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The file contains the results analysis
When the data will become available and for how long
Six months after the completion of the project
To whom data/document is available
ethics committee
With the permission of the researchers
Under which criteria data/document could be used
In accordance with the informed consent form and the proposal approved
Use of information can only be done anonymously
For the purpose of verifying and approving the original proposal
Only researchers related to this project will have access to information
If approved by the Research Vice-President of the University and the Ethics Committee: The use of other people for other research purposes will be possible.
From where data/document is obtainable
responsible person of project
email
Dr. Kamran Bagheri Lankarani
What processes are involved for a request to access data/document
Ask official request from the Deputy of Research and Technology(SUMS).