Protocol summary

Summary
The aim of are study is Effect of acid-base balance on cytokines serum level and outcome of renal transplant and the accessory purposes are evaluation of Creatinine and urea during seven days after surgery in two groups and evaluation of 24 hours urine out put in two groups during seven days after surgery and evaluation of immunologic markers (cytokines serum level IL-2,IL-10,INF-y) in two groups of our study.each of two group contain of 40 patient who has End stage renal disease that aged between 18 to 70 years old candidate for renal transplant from alive donor.Exclusion criteria : Patient with sever heart disease; Metabolic Acidosis with PH < 7.15 ; Duration of operation time >3 hours ;Body temperature Axillary < 35 or >38.5 degree centigrade; requirement for transfusion ; age>70 year or <18 year ; Renal transplantation form cadaver; Unsatisfactory of patient ; History of tumor or immunology Disease ; Received immunomedullatory drug. The aim of are study is Effect of acid-base balance on cytokines serum level and outcome of renal transplant and the accessory purposes are evaluation of Creatinine and urea during seven days after surgery in two groups and evaluation of 24 hours urine out put in two groups during seven days after surgery and evaluation of immunologic markers (cytokines serum level IL-2,IL-10,INF-y) in two groups of our study.Improvement surgical condition such as correction acidosis influence to immunologic markers and outcome.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015092712203N4
Registration date: 2016-06-02, 1395/03/13
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-06-02, 1395/03/13
Registrant information
Name
Niloufar Massoudi
Name of organization / entity
Shahid Beheshti University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 26 3250 6961
Email address
nmasoudi@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for Anesthesia research center of Shahiid Beheshti University of Medical Sciences .
Expected recruitment start date
2016-05-21, 1395/03/01
Expected recruitment end date
2016-08-22, 1395/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of acid-base balance on cytokines serum level and outcome of renal transplant
Public title
Effect of acid-base balance on cytokines serum level and outcome of renal transplant
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : Patient with End Stage Renal Disease who candidate for renal transplantation form live donor; Patient aged between 18-70 year; Patient satisfied to cooperate in this proposal. Exclusion criteria : Patient with sever heart disease; Metabolic Acidosis with PH < 7.15 ; Duration of operation time >3 hours ;Body temperature Axillary < 35 or >38.5 degree centigrade; requirement for transfusion ; age>70 year or <18 year ; Renal transplantation form cadaver; Unsatisfactory of patient ; History of tumor or immunology Disease ; Received immunomedullatory drug.
Age
From 18 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shahiid Beheshtie University of Medical Sciences
Street address
Shahiid Beheshti University, Arabi Avenue , Velenjak ,Tehran .
City
Tehran
Postal code
Approval date
2016-01-03, 1394/10/13
Ethics committee reference number
IR.SBMU.RAM.REC.1394.390

Health conditions studied

1

Description of health condition studied
Renal Failure
ICD-10 code
N19
ICD-10 code description
Renal Failure

Primary outcomes

1

Description
Serum level of IFN-y
Timepoint
Befor induction of anesthesia and aftre end of surgery.
Method of measurement
Elisa Test

2

Description
Serum level of IL-2
Timepoint
Befor induction of anesthesia and aftre end of surgery.
Method of measurement
Elisa Test

3

Description
Serum level of IL10
Timepoint
Befor induction of anesthesia and aftre end of surgery.
Method of measurement
Elisa Test

Secondary outcomes

1

Description
Cratinine
Timepoint
After surgery for one week
Method of measurement
Serum Level base on labratory base

2

Description
Urine output 24 hours
Timepoint
After surgery for one week
Method of measurement
Base of urine weight

3

Description
BUN
Timepoint
After surgery for one week
Method of measurement
Serum Level base on labratory base

4

Description
Urine output 24 hours
Timepoint
After surgery for one week
Method of measurement
Base of urine weight

Intervention groups

1

Description
Control Group : same volume of Intervention Group received saline
Category
Treatment - Drugs

2

Description
Intervention Group :sodium bicarbonate base on Arterial Blood Gas Test.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Modarres Hospital
Full name of responsible person
Nilofar Massoudi
Street address
Modarres Hospital,Faraz Bollvar, Saadatabad ,Tehran.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Anesthesiology Research Center Of Shahid Beheshti University OF Medical Sciences
Full name of responsible person
Ali Dabbagh,MD
Street address
Talaghani Hospital , Arabi Avenue ,Velenjak, Tehran.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Anesthesiology Research Center Of Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nilofar Massoudi
Position
MD/Assistant Professor
Other areas of specialty/work
Street address
Moddares Hospital , Faraz Bollvar ,Saadatabad, Tehran.
City
Tehran
Postal code
Phone
+98 22432575
Fax
Email
nilofarma@yahoo.com ; Fsafari@sbum.ac.ir; Alidabbagh@qums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University
Full name of responsible person
Nilofar Massoudi
Position
MD/Assistant professor
Other areas of specialty/work
Street address
Moddares Hospital , Faraz Bollvar ,Saadatabad, Tehran
City
Tehran
Postal code
Phone
+98 22432575
Fax
Email
nilofarma@yahoo.com; Fsafari@sbum.ac.ir; Alidabbagh@qums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University
Full name of responsible person
Navid Noraee
Position
MD / Assistanr professor
Other areas of specialty/work
Street address
Moddares Hospital , Faraz Bollvar ,Saadatabad, Tehran
City
Tehran
Postal code
Phone
+98 22432575
Fax
Email
nilofarma@yahoo.com ; Fsafari@sbum.ac.ir ; Alidabbagh@qums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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