kidney transplantation is the final treatment of ESRD patients.A major limitation of this method is the shortage of organ donations.The other hand, an aging population and an increasing number of patients with ESRD leads to an increased need to kidney transplantation.So trend to use marginal kidneys have increased.
One of the problems in the process of organ transplantation Which leads to dysfunction of the transplanted kidney,are Ischemia and reperfusion.Therefore, ways to avoid or treat Ischemia and reperfusion May lead to improved results, particularly of marginal cadaveric kidney transplantation. One way in which numerous studies have shown beneficial are Remote Ischemic Preconditioning. Remote Ischemic Preconditioning Means of creating transient ischemia in an organ to protect the fonction of another ischemic organ.As in organ transplantation or post-infarction occurs.Although most studies which have been done,were on the subject of myocardial infarction or stroke .the conventional method of RIP is to conect Blood pressure cuff on the limb of a patient And Wind it up to 200 mm Hg and After 10 minutes, we emptied cuff.10 minutes later we repeated the same action and This is repeated 2 to 3 times.And then the main ischemic process like Liver or kidney transplants, are performed.there are limited clinical trial studies which evaluate the protective effect of Remote Ischemic Preconditioning.In this study we tryto evaluate the protective effect of RIP on cadaveric kidney function .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017042333489N2
Registration date:2017-06-14, 1396/03/24
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-06-14, 1396/03/24
Registrant information
Name
Salman Soltani
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3802 2553
Email address
soltanis@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
From Mashhad University of Medical Sciences Research sources
Expected recruitment start date
2015-03-20, 1393/12/29
Expected recruitment end date
2016-03-19, 1394/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
evaluating the effect of remote ischemic preconditioning on cadaveric transplanted kidney function
Public title
evaluating the effect of remote ischemic preconditioning on cadaveric transplanted kidney function
Purpose
Prevention
Inclusion/Exclusion criteria
(Inclusion criteria:all the cadaveric donors which are admitted to the Montaserieh hospital and enrolled in the service of a single surgical group)
(Exclusion criteria:The patients ready for second transplantation;unstable cadaveric patints;the single kidney patients;the lower limbs traumatic patients;Patient dissatisfaction; when the kidneys are transplanted as en block to a recipient;Patients with advanced diabetes and vascular disease of the lower extremities; Persons under 12 years; adults over 55 years are excluded)
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mashhad University of Medical Sciences
Street address
Qureshi building ,University Avenue
City
mashhad
Postal code
Approval date
2014-09-23, 1393/07/01
Ethics committee reference number
IR.mums.rec.1393.23922690
Health conditions studied
1
Description of health condition studied
kidney transplantation
ICD-10 code
N18
ICD-10 code description
Chronic kidney disease
Primary outcomes
1
Description
primary transplanted kidney function
Timepoint
after kidney transplantation we evaluate the urine volume every hour and check serum creatinin level 2,12 and 24 hour after sugery.and then daily upto one week and so every week upto one month.
Method of measurement
after kidney transplantation we evaluate the urine volume every hour and check serum creatinin level 2,12 and 24 hour after sugery.and then daily upto one week and so every week upto one month.we calculate GFR of patient with MDRD formula.
Secondary outcomes
1
Description
Need to dialysis again
Timepoint
after kidney transplantation we evaluate the urine volume every hour and check serum creatinin level 2,12 and 24 hour after sugery.and then daily upto one week and so every week upto one month.we calculate GFR of patient with MDRD formula.
Method of measurement
after kidney transplantation we evaluate the urine volume every hour and check serum creatinin level 2,12 and 24 hour after sugery.and then daily upto one week and so every week upto one month.we calculate GFR of patient with MDRD formula.
Intervention groups
1
Description
In the intervention group who are selected randomly, the blood pressure Cuff on the right leg at the hip of receiver are closed And inflated to 200mmHg And 10 minutes at the same pressure remains.then The cuff become completely empty.And then the cuff is attached to left thigh and Up to 200 mmg inflated for 10 minutes.And then goes empty.and then The organ donation is done routinely.
Category
Prevention
2
Description
In the control group blood pressure cuff is closed on the patient's lower extremity but it is not inflated
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Montaserieh Hospital
Full name of responsible person
Dr salman soltani
Street address
Chamran Avenue
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mahmood Tavakkoli
Street address
Daneshgah Avenue
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Montaserie Hospital, Mashhad University of Medical Sciences