The aim of present study is to evaluate the sertraline effect on hypotension during hemodialysis. In a single center clinical trial study, 30 patients with hypotension during hemodialysis who referred to Imam Reza Hospital of Tabriz University of Medical Sciences will select. This study will be done in a single group, due to low number of available patients. Systolic blood pressure, diastolic blood pressure, heart rate, and mean arterial pressure of patients will record before intervention during hemodialysis. Patients will receive 50 mg sertraline daily for two weeks. Systolic blood pressure, diastolic blood pressure, heart rate, and mean arterial pressure of patients will record again during hemodialysis. Systolic blood pressure changes, diastolic blood pressure changes, heart rate changes, and mean arterial pressure changes are as primary variables and side effects are as secondary variables.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201604273742N4
Registration date:2016-09-09, 1395/06/19
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-09-09, 1395/06/19
Registrant information
Name
Hamid Noshad
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1541 5023
Email address
noshadh@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tabriz University of Medical Sciences.
Expected recruitment start date
2016-05-21, 1395/03/01
Expected recruitment end date
2016-06-20, 1395/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Sertraline effect on hypotension during hemodialysis
Public title
Sertraline effect on hypotension during hemodialysis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age between 18 to 75 years old; resistant hypotension during hemodialysis; no specific reason for resistant hypotension; informed consent to participate in the study. Exclusion criteria: use of any selective serotonin reuptake inhibitors.
Age
From 18 years old to 75 years old
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
Tabriz University of Medical Sciences.
Street address
Tabriz University of Medical Sciences, Daneshgah Street, Tabriz, Eastern Azerbaijan, Iran.
City
Tabriz
Postal code
Approval date
2015-11-23, 1394/09/02
Ethics committee reference number
TBZMED.REC.1394.855
Health conditions studied
1
Description of health condition studied
Hemodialysis
ICD-10 code
Z99.2
ICD-10 code description
Dependence on renal dialysis
Primary outcomes
1
Description
Systolic blood pressure
Timepoint
Beginning of study, two weeks later.
Method of measurement
Measuring blood pressure
2
Description
Diastolic blood pressure
Timepoint
Beginning of study, two weeks later.
Method of measurement
Measuring blood pressure
3
Description
Heart rate
Timepoint
Beginning of study, two weeks later.
Method of measurement
clinical examination
4
Description
Mean arterial pressure
Timepoint
Beginning of study, two weeks later.
Method of measurement
Measuring blood pressure
Secondary outcomes
1
Description
Adverse effects
Timepoint
Two weeks later
Method of measurement
Patient follow up
Intervention groups
1
Description
This study will be done in a single group, due to low number of available patients. Systolic blood pressure, diastolic blood pressure, heart rate, and mean arterial pressure of patients will record before intervention during hemodialysis. Patients will receive 50 mg sertraline daily for two weeks. Systolic blood pressure, diastolic blood pressure, heart rate, and mean arterial pressure of patients will record again during hemodialysis.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam-Reza Hospital
Full name of responsible person
Dr Hamid Noshad
Street address
Imam-Reza Hospital of Tabriz University of Medical Sciences, Daneshgah Street, Tabriz, Eastern Azerbaijan, Iran.
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of Medical Sciences.
Full name of responsible person
Dr Hasan Soleimanpour
Street address
Deputy of Research and Technology, Central Building of Number Two, Tabriz University of Medical Sciences, Daneshgah Street, Tabriz.
City
Tabriz
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, Tabriz 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
Tabriz University of Medical Sciences.
Full name of responsible person
Dr Hamid Noshad
Position
Subspecialty Nephrology
Other areas of specialty/work
Street address
Faculty of Medicine, Tabriz University of Medical Sciences, Daneshgah Street, Tabriz.
City
Tabriz
Postal code
Phone
+98 41 3541 5023
Fax
Email
medicalresearchtbz@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences.
Full name of responsible person
Dr Hamid Noshad
Position
Subspecialty of Nephrology
Other areas of specialty/work
Street address
Faculty of Medicine, Tabriz University of Medical Sciences, Daneshgah Street, Tabriz.
City
Tabriz
Postal code
Phone
+98 41 3541 5023
Fax
Email
medicalresearchtbz@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences.
Full name of responsible person
Dr Reza Ghorbani
Position
Assistant of Internal Medicine
Other areas of specialty/work
Street address
Faculty of Medicine, Tabriz University of Medical Sciences, Daneshgah Street, Tabriz.
City
Tabriz
Postal code
Phone
+98 41 3541 5023
Fax
Email
medicalresearchtbz@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)