Protocol summary

Study aim
Determining the effect of linear, step- wise and functional ultrafiltration profiling on hypotension during dialysis in patients with chronic renal failure
Design
clinical trial with a control group in format of Latin square design , one-sided blind, randomized
Settings and conduct
The intervention site is hemodialysis. unites. For all patients, 4 different ultrafiltration protocols will be implemented. Protocols 1 include linear profiles, protocol 2: stack profiles, protocol 3: functional profiles, protocol 4: fixed ultrafiltration profiles, each of which will run for each group for 2 weeks.For each protocol, 6 hemodialysis sessions are considered and patients undergo hemodialysis 3 times a week and 4 hours each time. Patients' blood pressure will be controlled at each session in 5 times: before hemodialysis, at the first hour, second hour, third hour and after hemodialysis in the half-sitting position of the patient's arm.
Participants/Inclusion and exclusion criteria
Getting end stage renal failure Hemoglobin>10 History of dialysis 3 months at least Dialysis 3 times a week Systolic blood pressure above 100 mm Hg before dialysis Not use anti-hypertensive medication 4 hours before dialysis Exclusion criteria: Classes 3 and 4 of Heart Failure Hepatic Impairment
Intervention groups
32 patients will be randomly blocked into four groups. Each block contains the letters A, B, C, and D, which patients will randomly place in these blocks. Then, the four groups will receive four different treatment protocols. Subjects in Group A will first receive Protocol 1, then 2, 3, and 4. Group B receives protocol 2, then 3, 4 and 1. Group C will also receive protocols 3, 4, 1 and 2, respectively. Group D will receive protocol 4, then 3, 2, and 1.
Main outcome variables
Blood pressure

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20140802018649N4
Registration date: 2019-07-08, 1398/04/17
Registration timing: prospective

Last update: 2019-07-08, 1398/04/17
Update count: 0
Registration date
2019-07-08, 1398/04/17
Registrant information
Name
Khadijeh Yazdi
Name of organization / entity
Golestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 17 1442 6900
Email address
yazdi@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-20, 1398/04/29
Expected recruitment end date
2019-09-13, 1398/06/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of liner, step-wise and functional ultrafiltration profiling on hypotension during hemdialysis in patients with chronic renal failure
Public title
Effect of ultrafiltration profiling on hypotention during hemodialysis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
getting end stage renal failure hemoglobin>10 history of dialysis 3 months at least Dialysis 3 times a week Systolic blood pressure above 100 mm Hg before dialysis Not use anti-hypertensive medication 4 hours before dialysis
Exclusion criteria:
Classes 3 and 4 of Heart Failure Hepatic Impairment
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 32
Randomization (investigator's opinion)
Randomized
Randomization description
32 patients will be randomly blocked into four groups. Each block contains the letters A, B, C, and D, which patients will randomly place in these blocks. Then, the four groups will receive four different treatment protocols. Subjects in Group A will first receive Protocol 1, then 2, 3, and 4. Group B receives protocol 2, then 3, 4 and 1. Group C will also receive protocols 3, 4, 1 and 2, respectively. Group D will receive protocol 4, then 3, 2, and 1.
Blinding (investigator's opinion)
Single blinded
Blinding description
The patient does not know that will be in which one of the four groups of treatment protocols.
Placebo
Not used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Golestan University of Medical Sciences
Street address
Booyeh Nursing and Midwifery Faculty, Falsafi educational Campus, Beginning of Shast Kola Road, Gorgan
City
Gorgan
Province
Golestan
Postal code
4934174515
Approval date
2019-02-17, 1397/11/28
Ethics committee reference number
IR.GOUMS.REC.1398.002

Health conditions studied

1

Description of health condition studied
Chronic kidney disease
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease

Primary outcomes

1

Description
Blood pressure
Timepoint
before hemodialysis, 1 hour, 2 hours, 3 hours and after hemodialysis
Method of measurement
sphygmomanometer

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group1: group will receive ultrafiltration profiles in the form of protocols, each protocol will be implemented for a period of 2 weeks and overall 8 weeks as below.At first, Protocol 1 include linear profiles of ultrafiltration, then protocol 2 including stepwise profiles, protocol 3 including functional profiles of ultrafiltration and protocol 4 include of fixed ultrafiltration, each one for 2 weeks.
Category
Treatment - Other

2

Description
Intervention group2: group will receive ultrafiltration profiles in the form of protocols, each protocol will be implemented for a period of 2 weeks and overall 8 weeks as below.First, protocol 2 included a stepwise profile , then protocol 3: functional profile, protocol 4 include of fixed ultrafiltration, and protocol 1 containing linear ultrafiltration, each one for 2 weeks.
Category
Treatment - Other

3

Description
Intervention group3: group will receive ultrafiltration profiles in the form of protocols, each protocol will be implemented for a period of 2 weeks and overall 8 weeks as below. First, protocol 3 includes functional profiles, then protocol 4 including fixed ultrafiltration, next protocol 1 of linear ultrafiltration, and at the end protocol 2, including stapwise ultrafiltration profiles, each one for 2 weeks.
Category
Treatment - Other

4

Description
Intervention group: group will receive ultrafiltration profiles in the form of protocols, each protocol will be implemented for a period of 2 weeks and overall 8 weeks as below.First, protocol 4 including fixed ultrafiltration, then protocol 1 of linear ultrafiltration, next protocol 2, including stapwise ultrafiltration and at the end protocol 3 includes functional profiles, each one for 2 weeks.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Payambar Azam Hospital
Full name of responsible person
Fatemeh Barani
Street address
Beginning of the road Incheh Broun, Gonbad Kavoos
City
Gonbad Kavoos
Province
Golestan
Postal code
4934174515
Phone
+98 17 3328 0121
Email
yazdi@goums.ac.ir
Web page address
http://goums.ac.ir/index.php?slc_lang=fa&sid=130

2

Recruitment center
Name of recruitment center
Shahid Motahhri hospital
Full name of responsible person
Enseaeh Yousofzadeh
Street address
East of Taleghani Street, Student Blvd. intersection, Shahid Motahari Hospital
City
Gonbad
Province
Golestan
Postal code
4934174515
Phone
+98 17 3355 1111
Email
yazdi@goums.ac.ir
Web page address
http://goums.ac.ir/index.php?sid=79&slc_lang=fa

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Mohammad Reza Honarvar
Street address
Shast Kola road, Falsafi campus, Deputy of research and technology
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3245 1660
Email
yazdi@goums.ac.ir
Web page address
http://goums.ac.ir/index.php?slc_lang=fa&sid=12
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gorgan 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
Gorgan University of Medical Sciences
Full name of responsible person
Khadijeh Yazdi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shast Kola road, Falsafi Campus, booyeh Nursing and Midwifery school
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3245 6900
Fax
+98 17 3242 5171
Email
yazdi@goums.ac.ir
Web page address
http://goums.ac.ir/

Person responsible for scientific inquiries

Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Saeid Amir Khanloo
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Sast Kola Road, Fasafi educational campus, Medical Faculty
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3245 1442
Fax
+98 17 3242 5171
Email
amirkhanloo@goums.ac.ir
Web page address
http://goums.ac.ir/cv/899/dramirkhanloo/

Person responsible for updating data

Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Khadijeh Yazdi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Sast Kola road, Falsafi educational campus, Nursing and Midwifery Faculty
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3245 6900
Fax
+98 17 3242 5171
Email
yazdi@goums.ac.ir
Web page address
http://goums.ac.ir/cv/2403/drkhyazdi/

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
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
The protocol and analyzing method and the results will be published in the form of a report of the project and the scientific paper
When the data will become available and for how long
3 months after submitting the results to the relevant organization
To whom data/document is available
Academic researchers and for nurses who are working in hemodialysis units.
Under which criteria data/document could be used
Just to improve the provision of patient care and research work
From where data/document is obtainable
Khadijeh Yazdi
What processes are involved for a request to access data/document
The request is sent by email to be answered by the research team as soon as possible after review.
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