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The effect of distance of needle on the Dialysis Adequacy in hemodialysis patients in Razi Educational and Medical Hospital in Rasht.

Protocol summary

Study aim
The effect of direction and distance of needle on the Dialysis Adequacy in hemodialysis patients in Razi Educational and Medical Hospital in Rasht.
Design
A controlled clinical trial, with parallel groups, without blinding, randomized, on 60 patients undergoing hemodialysis. To randomize from Sealed Envelope Ltd. online randomization service 2019 was used.
Settings and conduct
This study will be performed on hemodialysis patients at Razi Hospital in Rasht in 2021. The Dagdras formula will also be used to measure dialysis adequacy. To measure BUN before and after dialysis, a blood sample will be taken from the arterial route immediately before the start of hemodialysis and at the last minute.
Participants/Inclusion and exclusion criteria
Hemodialysis patients with a minimum age of 18 years, patients with the end-stage renal disease with hemodialysis at least three times a week for four hours per session, a history of at least three months of dialysis, having a venous arterial fistula, completing the duration of dialysis in all sessions, Blood flow rate of at least 250 ml/min and dialysis flow rate of 500 ml/min will be entered. Exclusion criteria will include the need for cardiopulmonary resuscitation, incomplete dialysis sessions, and the patient's lack of cooperation for any reason.
Intervention groups
In this study, the control group will be the last dialysis session of each patient before the intervention. Eligible patients were randomly divided into two groups with random blocking, the experimental group with a distance of 3 cm and in the opposite direction, the experimental group with a distance of 6 cm and in the opposite direction.
Main outcome variables
Measurable outcome includes dialysis adequacy in hemodialysis patients.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20201009048977N1
Registration date: 2020-10-17, 1399/07/26
Registration timing: prospective

Last update: 2020-10-17, 1399/07/26
Update count: 0
Registration date
2020-10-17, 1399/07/26
Registrant information
Name
Samad Karkhah
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4723 2208
Email address
sami.karkhah@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-05, 1399/08/15
Expected recruitment end date
2021-02-03, 1399/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of distance of needle on the Dialysis Adequacy in hemodialysis patients in Razi Educational and Medical Hospital in Rasht.
Public title
The effect of distance of needle on the Dialysis Adequacy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients undergoing hemodialysis whose chronological age was above 18 solar years Patients with end-stage renal disease who underwent hemodialysis at least three times a week for four hours per session History of at least three months of dialysis Having a venous arterial fistula Complete the duration of dialysis in all sessions The blood flow rate of at least 250 ml per minute The dialysis flow rate of 500 ml per minute
Exclusion criteria:
Need for cardiopulmonary resuscitation Incomplete dialysis sessions Patient non-cooperation for any reason
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
More than 1 sample in each individual
Number of samples in each individual: 3
The adequacy of dialysis will be measured in three consecutive sessions by changing the direction and distance of arteriovenous needles by Kt/V based method.
Randomization (investigator's opinion)
Randomized
Randomization description
The initial sampling method is convenience sampling and the main sampling of the present study will be block randomization. Patients who met the inclusion criteria were randomly divided into two groups of block randomization with the size of 4 and 6 blocks, the experimental group with a distance of 3 cm and in the opposite direction, the experimental group with a distance of 6 cm and in the opposite direction. To generate a randomization list from the online randomization service Sealed Envelope Ltd 2019 was used.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Guilan University of Medical Sciences
Street address
Shahid Beheshti St.
City
Rasht
Province
Guilan
Postal code
39841-41469
Approval date
2020-10-07, 1399/07/16
Ethics committee reference number
IR.GUMS.REC.1399.321

Health conditions studied

1

Description of health condition studied
Hemodialysis patients
ICD-10 code
Z49
ICD-10 code description
Encounter for care involving renal dialysis

Primary outcomes

1

Description
Dialysis adequacy
Timepoint
Immediately before the start of hemodialysis and in the last minutes of hemodialysis
Method of measurement
Blood BUN measurement and calculation based on the Daugirdas-II formula

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: With a distance of 3 cm and in the opposite direction
Category
Treatment - Other

2

Description
Intervention group: With a distance of 6 cm and in the opposite direction
Category
Treatment - Other

3

Description
Control group: The last dialysis session of each patient before the intervention
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Razi Hospital, Rasht
Full name of responsible person
Samad Karkhah
Street address
Sardar Jangal Street
City
Rasht
Province
Guilan
Postal code
41448
Phone
+98 13 3354 1001
Email
sami.karkhah@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Mohammad Taqi Moghaddam Nia
Street address
Shahid Beheshti St.
City
Rasht
Province
Guilan
Postal code
13111-41937
Phone
+98 13 3332 6061
Email
moghaddamnia92@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rasht 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
Rasht University of Medical Sciences
Full name of responsible person
Mohammad Taqi Moghaddam Nia
Position
Assistant Professor of Guilan University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Health in Emergency and Disaster
Street address
Shahid Beheshti St.
City
Rasht
Province
Guilan
Postal code
13111-41937
Phone
+98 13 3332 6061
Email
moghaddamnia92@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Mohammad Taqi Moghaddam Nia
Position
Assistant Professor of Guilan University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Health in Emergency and Disaster
Street address
Shahid Beheshti St.
City
Rasht
Province
Guilan
Postal code
13111-41937
Phone
+98 13 3332 6061
Email
moghaddamnia92@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Samad Karkhah
Position
Master Nursing Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shahid Beheshti St.
City
Rasht
Province
Guilan
Postal code
13111-41937
Phone
+98 51 4723 2208
Fax
Email
sami.karkhah@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is 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
Title and more details about the data/document
Only part of the data, such as information about the main outcome or the like, can be shared.
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
It will be available only to researchers working in academic and scientific institutions
Under which criteria data/document could be used
Researchers in the field of hemodialysis on request
From where data/document is obtainable
Communicate with the authors of the present study via email
What processes are involved for a request to access data/document
Communicate with the authors of the present study via email
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