Protocol summary

Summary
Pruritus a common problem in dialysis patients, is sometimes precipitated or exacerbated by dialysis. Pruritus appearing only during treatment, especially if accompanied by other allergic symptoms, may be a manifestation of low grade hypersensivity to dialyser or blood circuit components. More often than not, however, pruritus is simply present chronically and is noticed in the course of the treatment while the patient is forced to sit still for a prolonged period of time. Viral or drug induced hepatitis should be overlooked as a potential cause of such itching. Standard symptomatic treatment using antihistamines are useful. Odansetron and naltroxan have failed to help in randomized trials. Acupuncture has helped chronically, general moisturizing and lubrication of skin using emollients recommended. Ultraviolet light therapy, especially UVB light, may be of help. Pruritus often is found in patient with elevated serum ca*p product and or substantially elevated PTH level. Reduction in ca, p, and PTH are indicated. Whether uremic pruritus is helped by an increase dose of dialysis, use of high flux or polymethylacrylate membrane, capsaicin cream and activated charcoal, tacrolimus ointment or erythropointin remain question for further investigations. Because uremic pruritus is common in 42-75 of hemodialysis patients and accompanied with sleep disorder, depression, disturbed quality of life and mortality, treatment is important. 50 patients chronically hemodialysed that dialysed 3 per week and have chronic pruritus more than 4 weeks selected. They should not use antihistamin, lubricantor gabapenthin. Randomly half of them take sertraline 50 mg 2 times per day and half take placebo. Pruritus evaluated in second, fourth, sixth and eighth week, scoring with DOU and VAS score done. In DOU evaluate severity, distribution and sleep disorder. In VAS we ask the patient that how much that feel pruritus and score from 1 to 10 and then sum DOU and VAS. In the beginning and end of study we check lab data: CBC, BUN, Cr, Na, K, AST, ALT, Ca, P, TG, CHOL, LDL, HDL, FBS, and PTH.

General information

Acronym
uremic pruritis (UP)
IRCT registration information
IRCT registration number: IRCT2014080918736N1
Registration date: 2014-09-05, 1393/06/14
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-09-05, 1393/06/14
Registrant information
Name
Noushin Hashemi
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3450 2572
Email address
stud1284855031@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
vice chancellor for research shiraz university of medical science and researcher
Expected recruitment start date
2014-06-21, 1393/03/31
Expected recruitment end date
2015-04-20, 1394/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of sertraline on uremic pruritis in hemodialysis patient
Public title
The effect of sertraline on uremic pruritis in hemodialysis patient
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: chronic pruritus more than 4 weeks that is resistant to other therapies; do not use lubricating in recent 2 weeks and gabapenthin or antihistamines in recent 1 month; do not have hepatic failure. Excusion criteria: ca*p >55; PTH>500; p>5.5; SLE patients that recieve cellcept or azathioprine.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
vice chancellor for research shiraz university of medical sciences
Street address
Zand street
City
Shiraz
Postal code
7193711351
Approval date
2014-06-22, 1393/04/01
Ethics committee reference number
38519

Health conditions studied

1

Description of health condition studied
Uremic pruritus
ICD-10 code
N18.9
ICD-10 code description
Chronic kidney disease, unspecified

Primary outcomes

1

Description
Pruritus
Timepoint
Every 2 for two months
Method of measurement
DOU and VAS score

Secondary outcomes

empty

Intervention groups

1

Description
take sertraline pill the patient recieve setraline 50mg 2 times per day and evaluate in second ans fourth and sixth and eightth week
Category
Treatment - Drugs

2

Description
take placebo the patient recieve pacebo like setraline 2 times per day and evaluate in second and fourth and sixth and eightth week
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Ebrahimi Dialysis center
Full name of responsible person
Mr Rasti
Street address
Sadra city
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
vice chancellor for research shiraz university of medical sciences
Full name of responsible person
Dr. Seyed Basir Hashemi
Street address
Zand street
City
Shiraz
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 shiraz university of medical sciences
Proportion provided by this source
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

2

Sponsor
Name of organization / entity
Researcher
Full name of responsible person
Noushin Hashemi
Street address
Shiraz University of Medical Sciences
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Researcher
Proportion provided by this source
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
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Maryam Pakfetrat
Position
Faculty member
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences, Zand st.
City
Shiraz
Postal code
Phone
Fax
Email
pakfetratm@sums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Maryam Pakfetrat
Position
Nephrologist
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences, Zand st.
City
Shiraz
Postal code
Phone
Fax
Email
pakfetratm@sums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Noushin Hashemi
Position
MD, nephrology fellowship
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences, Zand st.
City
Shiraz
Postal code
Phone
Fax
Email
hashemi.noush@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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