Evaluation of Sertraline effect for Intradialytic Hypotensionin in the dialytic patients that has been referred to dialyse department of Kowsar hospital in Semnan
Objective: evaluation the effect of sertraline on hypotension during hemodialysis in dialysis patients referred to Semnan Kowsar hospital
Study design: Random (random blocks), one blind side, control with placebo, single central
Experimental population: at least 100 persons of hemodialysis patients in Semnan Kowsar hospital
Inclusion criteria: Permanent hemodialysis patients for the at least 3 months that in at least 50 percent of their hemodialysis cases in last 3 months, having intra-dialytic hypotension; perform at least 4 hours hemodialysis for 3 times per week; concentration of dialysis fluid: Na: 106 mEq/L, Ca: 5.2 mEq/L, K: 2 mEq/L and mg: 1 mEq/L, Cl: 111.5 mEq/L, HCO3 3.35; fluid dialysis flow: 500 to 600 ml/min; blood flow: 250 to 300 ml/min; antihypertensive agents received during dialysis; available for at least 8 weeks (study time).
Exclusion criteria: Performing hemodialysis in different treatment centers during the time of the study; having mental illness that use the SSRIs drug.
Sample size, intervention, intervention time and outcome of the study: sample size of this study is 100 persons will be divided into intervention and control group.
Intervention group: receive sertraline 50 mg daily (manufactured by Hayan Darou Company) in during first week and it is increased to 100 mg daily and patients are received sertraline 100 mg daily for another 3 weeks (total 4 weeks: due to that sertraline useful times of effectiveness is 4 weeks)
Control group: receive one placebo tablet daily (totally like sertraline but without therapeutic properties) for 4 weeks.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017080625732N23
Registration date:2017-08-15, 1396/05/24
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-08-15, 1396/05/24
Registrant information
Name
Alireza Emadi
Name of organization / entity
Semnan University of Medical Sciences, Semnan, Iran
Country
Iran (Islamic Republic of)
Phone
+98 23 3345 1336
Email address
are20935@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Semnan University of Medical Sciences
Expected recruitment start date
2017-01-04, 1395/10/15
Expected recruitment end date
2018-01-05, 1396/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Sertraline effect for Intradialytic Hypotensionin in the dialytic patients that has been referred to dialyse department of Kowsar hospital in Semnan
Public title
Evaluation of Sertraline effect for Intradialytic Hypotensionin in the dialytic patients that has been referred to dialyse department of Kowsar hospital in Semnan
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Permanent hemodialysis patients for the at least 3 months that in at least 50 percent of their hemodialysis cases in last 3 months, having intra-dialytic hypotension; perform at least 4 hours hemodialysis for 3 times per week; concentration of dialysis fluid: Na: 106 mEq/L, Ca: 5.2 mEq/L, K: 2 mEq/L and mg: 1 mEq/L, Cl: 111.5 mEq/L, HCO3 3.35; fluid dialysis flow: 500 to 600 ml/min; blood flow: 250 to 300 ml/min; antihypertensive agents received during dialysis; available for at least 8 weeks (study time).
Exclusion criteria: Performing hemodialysis in different treatment centers during the time of the study; having mental illness that use the SSRIs drug.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee, Deputy of research and technology, Semnan University of Medical Sciences
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
Semnan
Postal code
3514799442
Approval date
2017-01-03, 1395/10/14
Ethics committee reference number
IR.semums.REC.1395.156
Health conditions studied
1
Description of health condition studied
hypotension
ICD-10 code
I95.9
ICD-10 code description
Hypotension, unspecified
Primary outcomes
1
Description
Serum creatinine level
Timepoint
Before, 12, 24 and 48 hours after intervention
Method of measurement
Exam
2
Description
Blood Urea Nitrogen (BUN)
Timepoint
Before, 12, 24 and 48 hours after intervention
Method of measurement
Exam
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: receive sertraline 50 mg daily (manufactured by Hayan Darou Company) in during first week and it is increased to 100 mg daily and patients are received sertraline 100 mg daily for another 3 weeks (total 4 weeks: due to that sertraline useful times of effectiveness is 4 weeks)
Category
Treatment - Drugs
2
Description
Control group: receive one placebo tablet daily (totally like sertraline but without therapeutic properties) for 4 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Kosar Hospital
Full name of responsible person
Maliheh Yarmohammadi
Street address
Kosar Hospital, Street Amin, Semnan
City
Semnan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences, Deputy of Research and Technology
Full name of responsible person
Mohammadreza Asgari
Street address
Semnan University of Medical Sciences, Deputy of Research and Technology, Basij Blvd, Semnan
City
Semnan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan University of Medical Sciences, Deputy of Research and Technology
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
Semnan University of Medical Sciences
Full name of responsible person
Maliheh Yarmohammadi
Position
Kidney and urethra
Other areas of specialty/work
Street address
Semnan University of Medical Sciences, Blvd Basij, Semnan
City
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Fax
+98 23 3344 8999
Email
are20935@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Maliheh Yarmohammadi
Position
Kidney and urethra
Other areas of specialty/work
Street address
Semnan University of Medical Sciences, Blvd Basij, Semnan
City
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Fax
+98 23 3344 8999
Email
are20935@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Maliheh Yarmohammadi
Position
Kidney and urethra
Other areas of specialty/work
Street address
Semnan University of Medical Sciences, Blvd Basij, Semnan
City
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Fax
+98 23 3344 8999
Email
are20935@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)