The objective of this randomized,single blind trial is to investigate the effect of sertralin on dialysis associated hypotention. In this study 20 patients who meet the inclusion/exclusion criteria will be recruited and randomly assigned into intervention or control group. The patients in the intervention group will receive sertralin. The patients in the control group will receive placebo.before dialysis blood pressure,lowest blood pressure during dialysis,afte dialysis blood pressure,number of therapeutic interventionwill be measured before and after the intervention and compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201112033043N3
Registration date:2012-01-06, 1390/10/16
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-01-06, 1390/10/16
Registrant information
Name
Simin Dashti-Khavidaki
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6695 4709
Email address
dashtis@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Science and Health Services
Expected recruitment start date
2011-10-23, 1390/08/01
Expected recruitment end date
2011-12-11, 1390/09/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
the effect of sertraline in dialysis associated hypotention
Public title
the effect of sertraline in dialysis associated hypotention
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion:patient suffer from dialysis associated hypotention
exclusion:systolic dysfunction,patients who can not tolerate sertraline's adverse effect,refusal to participate in the study,usage of midodrin
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
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
Tehran University of Medical Science and Health Services
Street address
Tehran University of Medical Science and Health Services,Poorsina Avenue
City
tehran
Postal code
Approval date
2011-11-26, 1390/09/05
Ethics committee reference number
90-8-21:1-8
Health conditions studied
1
Description of health condition studied
dialysis associated hypotention
ICD-10 code
Y84.1،I95
ICD-10 code description
Kidney dialysis،Hypotension
Primary outcomes
1
Description
hypotention
Timepoint
4weeks before intervention,during intervention,4weeks after intervention
Method of measurement
mmhg with use of digital barometer
Secondary outcomes
1
Description
complications of hypotention such as cramp,dizziness,headache,neusea and vomiting,
Timepoint
4weeks before intervention,during intervention,4weeks after intervention
Method of measurement
observation
Intervention groups
1
Description
treatment group:administration tablet of sertraline 50-100mg once daily for 8 weeks
Category
Treatment - Drugs
2
Description
control group:administration placebo of sertralin50-100mg once daily for 8 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini hospital
Full name of responsible person
Dr.Simin Dashti-Khavidaki
Street address
Dr Gharib Avenue,Keshavarz Boulevard
City
tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Science and Health Services
Full name of responsible person
Dr.Simin Dashti-Khavidaki
Street address
Department of clinical pharmacy, Faculty of pharmacy, Tehran University of Medical Science and Health Services,Poorsina Avenue
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Science and Health Services
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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Science and Health Services
Full name of responsible person
Dr.Simin Dashti-Khavidaki
Position
associated professor in clinical pharmacy
Other areas of specialty/work
Street address
Department of clinical pharmacy, Faculty of pharmacy, Tehran University of Medical Science and Health Services,Poorsina Avenue
City
Tehran
Postal code
Phone
+98 912 247 1998
Fax
Email
dashtis@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Science and Health Services
Full name of responsible person
Dr.Simin Dashti-Khavidaki
Position
associated professor in clinical pharmacy
Other areas of specialty/work
Street address
Department of clinical pharmacy, Faculty of pharmacy, Tehran University of Medical Science and Health Services,Poorsina Avenue
City
Tehran
Postal code
Phone
Fax
Email
dashtis@sina.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)