Evaluation of the effect of increased blood flow velocity compared with administration of activated charcoal suspension on severity of uremic pruritus in hemodialysis patients
Determination and Comparison of the Effect of Increasing of pamp rounds and Administration of Sharcol on Severe of Uremic Pruritus in Hemodialysis Patients
Design
Clinical trials are cross-over, without blindness, randomized
Settings and conduct
In this study, 60 patients with uremic pruritus who Referred to hemodialysis department of Imam Hossein Shahroud Hospital , will be randomly assigned to three groups A, B and C.According to the type of study for group A in the first period of first intervention,Group B is the second intervention and Group C is assihned a third intervention.After two weeks, the desired result is measured and one week wash out is considered .In the second and third period, interventions were arranged.
Participants/Inclusion and exclusion criteria
Be entry: orientation to the time, place, and person when collecting data
At least one month of uremic pruritus
Patient diagnosed with chronic renal failure
Under hemodialysis for at least 6 months
Perform hemodialysis three times a week for at least three hours
Proper vascular access
Determine the patient's dry weight
no entry: There is a skin rash causing itching
The presence of liver and biliary disease
Unwillingness to cooperate at each stage of the research
Blood pressure less than 60/100 mm Hg
Maladaptation or any digestive problem
Intervention groups
The present study is a cross-over clinical trial with three groups and three periods and three sequences.First intervention: Increasing blood flow rate to the hemodialysis machin for two weeks .Second Intervention:Daily administration of 6 grams of activated charcoal suspension for two weeks
.Third intervention: Administer 6 grams of activated charcoal suspension per day and change the same pump as the first intervention for two weeks.
Main outcome variables
pation pruritus
General information
Reason for update
Acronym
CKD.chronoc kidny disease ESRD. end stage renal disease
IRCT registration information
IRCT registration number:IRCT20180807040729N1
Registration date:2018-10-25, 1397/08/03
Registration timing:registered_while_recruiting
Last update:2018-10-25, 1397/08/03
Update count:0
Registration date
2018-10-25, 1397/08/03
Registrant information
Name
mahmoud zanganeh ghasemabadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3220 0371
Email address
zanganeh@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2019-03-16, 1397/12/25
Actual recruitment start date
2018-09-23, 1397/07/01
Actual recruitment end date
2019-03-16, 1397/12/25
Trial completion date
empty
Scientific title
Evaluation of the effect of increased blood flow velocity compared with administration of activated charcoal suspension on severity of uremic pruritus in hemodialysis patients
Public title
comparative study on the increase of blood flow velocity and administration of oral activated charcoal on the severity of uremic pruritus in hemodialysis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Be alert to the time, place, and individuals when collecting information
At least one month of uremic proritus
Patient diagnosed with chronic renal failure
Under hemodialysis for at least 6 months
Perform hemodialysis three times a week for at least three hours
Proper vascular access
Determine the patient's dry weight
Exclusion criteria:
There is a skin rash causing itching
The presence of liver and biliary disease
Unwillingness to cooperate at each stage of the research
Blood pressure less than 60/100 mm Hg
Malnutrition or any digestive problem
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were randomly assigned 6 blocks to 3 groups of 1, 2, 3 (each group of 20) using the software.
using the darkened and packed envelope, the dedicated sequence is hiding.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahroud University of Medical Sciences
Street address
Shahroud University of Medical Sciences, Hafte-Tir Sq., Tehran Street
City
shahroud
Province
Semnan
Postal code
3614773955
Approval date
2018-09-05, 1397/06/14
Ethics committee reference number
iR.SHMU.REC.1397.II8
Health conditions studied
1
Description of health condition studied
Uremic pruritus in hemodialysis patients
ICD-10 code
L29.8
ICD-10 code description
Other pruritus
Primary outcomes
1
Description
The incidence of itching according to the score of the questionnaire Yosipovich
Timepoint
The questionnaire will be completed in six steps:1- Before intervention in each group 2- Immediately after the first intervention in a triple group (first period) 3- After the first wash out in the first period 4- Immediately after the interventions defined in the second period 5. After the second wash out 6. Immediately after the interventions defined in the third period.
Method of measurement
The severity of itching will be measured using the Yosipovich questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
In this cross-over study, three therapeutic interventions are compared in three groups.In other words, all three groups will receive these three interventions cross-over.(And each intervention is considered as the control group for further interventions)and therefore does not need a separate control group(placebo) First intervention: increased blood flow rate in hemodialysis machine,In the first week of intervention, the dose was 25 ml / min and in the second week it was 50 ml, compared to the standard speed(4 ml per kg body weight). Second Intervention: Daily administration of 6 grams of activated charcoal suspension for two weeks.Third intervention: Administer 6 grams of activated charcoal suspension per day and change the same with the first intervention for two weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossien hospital
Full name of responsible person
Dr.Hossein ebrahimi
Street address
end of 28-meter Touhidi, Imam Khomeini Street
City
shahroud
Province
Semnan
Postal code
3614773955
Phone
+98 23 3234 2000
Fax
+98 23 3233 3902
Email
h_ebrahimi43@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Dr. Mohammad-Hassan Emamian
Street address
Shahroud University of Medical Sciences, Hafte-Tir Sq., Tehran Street
City
shahroud
Province
Semnan
Postal code
6314773955
Phone
+98 23 3239 5054
Email
emamian@shmu.ac.ir
Web page address
http://research.shmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahroud 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
Shahroud University of Medical Sciences
Full name of responsible person
Dr Hossein ebrahimi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahroud University of Medical Sciences, Hafte-Tir Sq., Tehran Street
City
shahroud
Province
Semnan
Postal code
6314773955
Phone
+98 23 3239 3811
Email
h_ebrahimi43@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Dr. Hossein ebrahimi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahroud University of Medical Sciences, Hafte-Tir Sq., Tehran Street
City
shahroud
Province
Semnan
Postal code
3617753917
Phone
+98 23 3239 3811
Email
h_ebrahimi43@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Dr. Hossein ebrahimi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahroud University of Medical Sciences, Hafte-Tir Sq., Tehran Street
City
shahroud
Province
Semnan
Postal code
36147753917
Phone
+98 23 3239 3811
Email
h_ebrahimi43@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD