This study will be conducted in order to comparison of direction and distances of needles of hemodialys on arteriovenous fistula recirculation in hemodialysis patients.
There is no control group in this study, We will be selected 22 end stage renal disease patients with AV fistula that they were on haemodialysis more than 3 months. .The degree of recirculation will be measured with Urea based two needle technique method.recirculation will be measured with urea based two needle technique method
recirculation Percent = ([P - A] ÷ [P - V]) x 100
During the four sessions of dialysis, direction and distance of needles for each patient will be change as follows: In first session, unidirectional needles with both directed to the heart and with a distance of 6 cm between them; In the second session, needles in opposite directions and with a distance of 6 cm between them; In the third session, unidirectional needles with both directed to the heart and with a distance of 3 cm between them; and in fourth session, needles in opposite directions and with a distance of 3 cm or more between them.
The following protocol will be used for blood sampling.The ultrafiltration will be turned off approximately 30 minutes after the initiation of Haemodialysis and then arterial and venous line samples will be obtained. Access blood flow will be reduced to 50 mL/min and 15 to 30 seconds later, the Peripheral blood sample from the arterial blood line will be obtained.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016082929581N1
Registration date:2016-11-29, 1395/09/09
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-11-29, 1395/09/09
Registrant information
Name
leila ghanbari afra
Name of organization / entity
Qom University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 25 3884 9038
Email address
lghanbari@muq.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Qom University of Medical Sciences
Expected recruitment start date
2016-09-10, 1395/06/20
Expected recruitment end date
2017-01-09, 1395/10/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of direction and distances of needles of hemodialys on arteriovenous fistula recirculation in hemodialysis patients
Public title
The comparison of direction and distances of needles of hemodialys on recirculation
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
1-End stage renal disease patients under hemodialysis, with at least three times on a week for four hours per session
2-having arteriovenous fistula
3-Iinitiation of hemodialysis for at least 6 months
4-Having good tolerance to dialysis and completing time of hemodialysis
5-Maintain blood flow rate for 350ml / min
6- Maintain dialysis fluid flow for 500ml / min
7- Use the same size dialyzers' membrane and same filter in all hemodialysis sessions
8-Use the one dialysis machine for one patient in all the hemodialysis sessions. Exclusion criteria:
1-cardiogenic shock during dialysis need to perform cardiopulmonary resuscitation
2-Unfinished dialyse sessions
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
22
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Qom University of Medical Sciences
Street address
Research deputy of Qom university of Medical Sciences, No. 83, 4 lane, 1/1 Ave., Safashahr St., Qom.
City
Qom
Postal code
3713614975
Approval date
2014-06-07, 1393/03/17
Ethics committee reference number
IR.muq.Rec.1394.7
Health conditions studied
1
Description of health condition studied
end stage renal disease
ICD-10 code
N18.5
ICD-10 code description
مرحله انتهایی بیماری کلیوی
Primary outcomes
1
Description
Decrease of recirculation Percent
Timepoint
Every other day
Method of measurement
The degree of recirculation will be measured with urea based two needle technique method recirculation Percent = ([P - A] ÷ [P - V]) x 100 P= Peripheral blood urea V= Intravenous blood urea A= The arterial blood urea.
Secondary outcomes
empty
Intervention groups
1
Description
In first session, unidirectional needles will be placed with both directed to the heart and with a distance of 6 cm between them.
Category
Treatment - Other
2
Description
In the second session, needles will be placed in opposite directions and with a distance of 6 cm between them.
Category
Treatment - Other
3
Description
In the third session, unidirectional needles will be placed with both directed to the heart and with a distance of 3 cm between them
Category
Treatment - Other
4
Description
in fourth session, needles will be placed in opposite directions and with a distance of 3 cm or more between them.