1. Home
  2. Approved trials
  3. » فارسی

The efficacy of cold ischemic therapy in the results of transplantation of renal insufficiency by assessing the level of Ngal (neutrophilic gelatinase-dependent lipocalin) in the venous kidney

Protocol summary

Study aim
1.Determine the efficacy of cold ischemic therapy in the results of transplantation of patients with renal insufficiency
Design
The study group is a candidate for renal transplantation from either a live or a cadaver.The sample size is 30.Clinical trial without control,the allocation is single arm,without blindness
Settings and conduct
30 patients undergoing transplantation during1397-1398are studied. After removing the kidney from the body,the kidney enters normal saline and ice, and cold ischemia begins and until the stage of ischemic transplantation Cold is continued.This time varies from person to person,depending on how much the kidney transplant and receptor are.A cold ischemic period is noted for each person.During renal transplantation surgery after anastomosis,5 minutes after removal of arterial clam,Blood sample renal renal vein is taken immediately and direction.
Participants/Inclusion and exclusion criteria
Inclusion criteria:In this plan 30 transplant patients in the period from 1397-98 who received either live birth or a member of the cadaver are enrolled in the study,and the criteria for non-entry will not be defined in this study.
Intervention groups
After removing the kidney from the bodybuilder,the kidney enters normal saline and ice,and cold ischemia begins and continues until the stage of cold ischemic transplantation continues.A cold ischemic period is noted for each person.During renal transplantation surgery,after anastomosis of the arteries and kidney vein,5 minutes after removing arterial clampus, a blood sample of renal vein renal transplanted,and for monitoring the venous NGAL level, keeping the principles intact to the lab And will be tested(ELISA).
Main outcome variables
1.The amount of Ngal in the blood of the recipient prior to surgery and its rate in intravenous venous renal transplantation during surgery

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20131218015841N4
Registration date: 2018-10-02, 1397/07/10
Registration timing: registered_while_recruiting

Last update: 2018-10-02, 1397/07/10
Update count: 0
Registration date
2018-10-02, 1397/07/10
Registrant information
Name
Gholamreza Pourmand
Name of organization / entity
Urology Research Center,Tehran University of Medical Sciences,Tehran,Iran
Country
Iran (Islamic Republic of)
Phone
+98 21 6634 8560
Email address
pourmand@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-23, 1397/06/01
Expected recruitment end date
2019-05-22, 1398/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of cold ischemic therapy in the results of transplantation of renal insufficiency by assessing the level of Ngal (neutrophilic gelatinase-dependent lipocalin) in the venous kidney
Public title
Evaluating Investigating the role of cold ischemic time in kidney transplantation results by measuring Ngal blood transfusion vein blood sample
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who are candidates for transplantation during the period from 1398 to 1397
Exclusion criteria:
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Vice chancellor in Research ,Tehran University of Medical Sciences
Street address
Emam Khomeini St
City
Tehran
Province
Tehran
Postal code
1136746911
Approval date
2018-06-22, 1397/04/01
Ethics committee reference number
IR.TUMS.VCR.REC.1397.173

Health conditions studied

1

Description of health condition studied
Kidney Transplantation
ICD-10 code
N19
ICD-10 code description
Unspecified kidney failure

Primary outcomes

1

Description
Measure the level of Ngal(Neutrophil Gelatinase Associated Lipocalin) blood transfusion venous blood
Timepoint
1-before the kidney Transplant 2-During surgery after anastomosis of the artery and vein
Method of measurement
Through Eliza's method

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In this project, 30 patients undergoing a live or cadaver-bonded transplant candidate undergo a renal renal vein 5 min after surgery for arterial anastomosis and kidney vein, 5 minutes after arterial clamping, and to measure venous NGAL levels With Ngal Crystal Day Kit , The laboratory is transmitted and ELISA is measured by the amount of lipocalin dependent on neutrophil gelatinase.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Dr.Masoud Khalili
Street address
Emam Khomeini St
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8560
Email
masoudkhalili565@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr.MohammadAli Sahraeian
Street address
Enghelab St
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 8163 3627
Email
farzaneh.bagherpoor@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Dr.masoud Khalili
Position
resident
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Emam Khomeini St
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8560
Email
masoudkhalili656@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr.Gholamreza Pourmand
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Urology
Street address
Emam Khomeini St
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8560
Email
gh_pourmand@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Farzaneh Bagherpour
Position
Laboratory expert
Latest degree
Bachelor
Other areas of specialty/work
Laboratory Medicine
Street address
Emam Khomeini St
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8560
Email
farzaneh.bagherpoor@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
Loading...