The purpose of this study is evaluation of the effects of oral mirtazapine on serum level of histamine and serotonin in dialysis patients suffering from chronic kidney disease.
Design
Clinical practice, non-control group, community based and pragmatic, 38 patients were evaluated before intervention and then intervention.
Settings and conduct
This study will be performed as a clinical trial before and after on patients receiving hemodialysis referring to the Department of Nephrology and Dialysis in Shahid Beheshti Hospital and Besat Hospital in Hamedan.
Participants/Inclusion and exclusion criteria
inclusion criteria:aged above 18 years old,diagnosis of end stage renal disease who receive dialysis 3 times a week with moderate, severe and very severe uremic pruritus.exclusion criteria:Hyperphosphatemia, diabetic neuropathy, and patients who are unable to work due to psychiatric disorders.
Intervention groups
Patients will receive 7.5 mg/day mirtazapine for two weeks.
Main outcome variables
Serum level of histamine and serotonin
General information
Reason for update
Acronym
-
IRCT registration information
IRCT registration number:IRCT20150629022965N18
Registration date:2018-08-04, 1397/05/13
Registration timing:registered_while_recruiting
Last update:2018-08-04, 1397/05/13
Update count:0
Registration date
2018-08-04, 1397/05/13
Registrant information
Name
Maryam Mehrpooya
Name of organization / entity
School of Pharmacy,Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3821 8684
Email address
m.mehrpoya@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-22, 1397/03/01
Expected recruitment end date
2018-08-23, 1397/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effects of mirtazapin on serum levels of histamin and serotonin in hemodialysis Patients suffering from uremic pruritus
Public title
Effects of mirtazapine on serum levels of histamin and serotonin
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
aged above 18
diagnosis of end stage renal disease
receiving dialysis 3 times a week
no history of dermatological disorder which result in feeling itch
no history allergen medications or foods
no history of receiving medication which relieve itch
presence of moderate, severe and very severe pruritus
Exclusion criteria:
pregnancy or lactation
presence of liver failure
presence of any psychiatric disorder
Hyperphosphatemia
diabetic neuropathy
Age
From 18 years old
Gender
Both
Phase
3
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
Ethics Committee of the Hamadan University of Medical Sciences
Street address
Hamadan University of Medical Sciences, In front of Luna park, Pazhouhesh Cross , Hamadan
City
Hamadan
Province
Hamadan
Postal code
6517619651
Approval date
2018-02-24, 1396/12/05
Ethics committee reference number
IR.UMSHA.REC.1396.819
Health conditions studied
1
Description of health condition studied
Chronic kidney disease
ICD-10 code
N18
ICD-10 code description
Chronic kidney disease (CKD)
Primary outcomes
1
Description
Serum level of histamine
Timepoint
at baseline and 14 days later
Method of measurement
ELISA kit
2
Description
Serum level of serotonin
Timepoint
at baseline and 14 days later
Method of measurement
ELISA kit
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: mirtazapine, 7.5 mg/day, for 14 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital of Hamadan
Full name of responsible person
Vida Sheikh
Street address
Shahid Beheshti Hospital, Eram Blvd, Hamadan, Iran.
City
Hamadan
Province
Hamadan
Postal code
3371-5-65179
Phone
+98 81 3838 7030
Email
vsh_57072@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Saeed Bashirian
Street address
Hamedan University of Medical Sciences, In front of Luna park, Pazhouhesh Cross , Hamadan, Iran.
City
Hamadan
Province
Hamadan
Postal code
6517838678
Phone
+98 81 3838 1010
Email
S_Bashirian@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Maryam Mehrpooya
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Hamedan University of Medical Sciences, In front of Luna park, Pazhouhesh Cross, Hamadan, Iran
City
Hamadan
Province
Hamadan
Postal code
6517838678
Phone
+98 81 3838 0717
Email
m_mehrpooya2003@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Maryam Mehrpooya
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Hamedan University of Medical Sciences, In front of Luna park, Pazhouhesh Cross, Hamadan, Iran
City
Hamadan
Province
Hamadan
Postal code
6517838678
Phone
+98 81 3838 0717
Email
m_mehrpooya2003@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Maryam Mehrpooya
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Hamedan University of Medical Sciences, In front of Luna park, Pazhouhesh Cross, Hamadan, Iran
City
Hamadan
Province
Hamadan
Postal code
6517838678
Phone
+98 81 3838 0717
Email
m_mehrpooya2003@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available