Objectives: The current study will aim to compare the effect of fluid therapy with normal saline and half saline on Creatinine level in patients after renal transplant. Design: This is a triple-blind, randomized clinical trial. Setting and conduct: One hundred patients using random block method were randomly assigned into two groups. In one group half saline serum plus 250 milliequivalents Sodium Bicarbonate and in the second group, normal saline serum plus 50 milliequivalents Sodium Bicarbonate will be infused. This clinical trial is a phase 3 study. This is a triple-blind randomized clinical trial. In this study, the patients, those who measure the outcomes of study (researchers) and Data Monitoring Committee (analyzers) will be unaware about intervention.
Inclusion criteria: Age between 18 to 65 years;
Exclusion criteria: The patient's potassium is higher than 5.5; Patients with chronic heart failure Ejection Fraction less than 30%; Patients with liver failure; The patient needs to have colloidal fluid and blood intake; Severe acidosis;
Main outcome measures (variables): The level of creatinine, urine volume, blood pressure, heart rate, blood BUN, etc. will be recorded on the first, second, third and seventh days after the intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017080535510N1
Registration date:2017-09-13, 1396/06/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-09-13, 1396/06/22
Registrant information
Name
Pejman Pourfakhr
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 4466 3963
Email address
pourfakhr@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2017-07-23, 1396/05/01
Expected recruitment end date
2017-10-23, 1396/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trials of effect of fluid therapy with half saline compared to normal saline on Creatinine level in post-renal transplant patients
Public title
Effect of fluid therapy on Creatinine level in post-renal transplant patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age between 18 to 65 years;
Exclusion criteria: The patient's potassium is higher than 5.5; Patients with chronic heart failure Ejection Fraction less than 30%; Patients with liver failure; The patient needs to have colloidal fluid and blood intake; Severe acidosis;
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Keshvarz Blvd
City
Tehran
Postal code
Approval date
2016-12-26, 1395/10/06
Ethics committee reference number
IR.TUMS.VCR.REC.1395.1565
Health conditions studied
1
Description of health condition studied
Chronic kidney disease
ICD-10 code
N18
ICD-10 code description
Chronic kidney disease
Primary outcomes
1
Description
Creatinine
Timepoint
In the first, second, third and seventh days after the intervention
Method of measurement
Blood test
2
Description
Urine volume
Timepoint
In the first, second, third and seventh days after the intervention
Method of measurement
Urine test
Secondary outcomes
1
Description
Systolic blood pressure
Timepoint
In the first, second, third and seventh days after the intervention
Method of measurement
Invasive blood pressure monitor
2
Description
Systolic blood pressure
Timepoint
In the first, second, third and seventh days after the intervention
Method of measurement
Invasive blood pressure monitor
3
Description
Heart rate per minute
Timepoint
In the first, second, third and seventh days after the intervention
Method of measurement
Invasive blood pressure monitor
Intervention groups
1
Description
Control group: Serum normal saline plus 50 mili-Equivalents Sodium Bicarbonate will be infused.
Category
Prevention
2
Description
Intervention group: Serum half Saline plus 250 mili-Equivalents Sodium Bicarbonate will be infused.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital of Tehran University of Medical Sciences
Full name of responsible person
Mohadeseh Shafiee
Street address
Hassan Abad square, Emam Khomeini Street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Sciences
Full name of responsible person
Dr. Masoud Yunesian
Street address
Tehran University of Medical Sciences, Keshavarz Blvd
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Mohadeseh Shafiee
Position
Student/Anesthesiology resident
Other areas of specialty/work
Street address
Tehran University of Medical Sciences, Keshavarz Blvd
City
Tehran
Postal code
Phone
+98 21 4466 3963
Fax
Email
mds.shafiei@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Pejmal Pourfakhr
Position
Faculty member/Anesthesiologist
Other areas of specialty/work
Street address
Tehran University of Medical Sciences, Keshavarz Blvd
City
Tehran
Postal code
Phone
+98 21 4466 3963
Fax
Email
pourfakhr@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohadeseh Shafiee
Position
Student/Anesthesiology resident
Other areas of specialty/work
Street address
Tehran University of Medical Sciences
City
Tehran
Postal code
Phone
+98 21 4466 3963
Fax
Email
mds.shafiei@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)