Protocol summary

Study aim
Comparison of Ultrafiltration Modeling and filtration dialysis in chronic dialysis patient on arterial oxygen content during dialysis
Design
A clinical trial with no control group, with no crossover, non-randomized, no placebo-controlled, single-center. Sample size is 80 patients.
Settings and conduct
Hemodialysis ward of Semnan Kowsar Hospital. Patients' oxygenation rate is assessed by ultrafiltration and dialysis.
Participants/Inclusion and exclusion criteria
Hemodialysis Patients Referred to Semnan Kowsar Hospital. Inclusion criteria: Dialysis patients over 18 years; Three months have elapsed since the patient began dialysis; No respiratory problems including asthma and respiratory disease. Exclusion criteria: Having metastatic lung cancer; Lack of informed consent.
Intervention groups
Intervention group 1: Patients undergo dialysis according to the one month protocol with a dialysis machine set up on ultra-filtration modeling. Intervention group 2: Patients according to protocol are dialyses in the second month by simple procedure.
Main outcome variables
Blood pressure; Filtration volume; Arterial blood oxygen levels.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20151228025732N49
Registration date: 2020-02-04, 1398/11/15
Registration timing: registered_while_recruiting

Last update: 2020-02-04, 1398/11/15
Update count: 0
Registration date
2020-02-04, 1398/11/15
Registrant information
Name
Alireza Emadi
Name of organization / entity
Semnan University of Medical Sciences, Semnan, Iran
Country
Iran (Islamic Republic of)
Phone
+98 23 3345 1336
Email address
are20935@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-22, 1398/07/30
Expected recruitment end date
2020-07-20, 1399/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Ultrafiltration Modeling and filtration dialysis in chronic dialysis patient on arterial oxygen content during dialysis
Public title
Comparison of Ultrafiltration Modeling and filtration dialysis in chronic dialysis patient on arterial oxygen content during dialysis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Dialysis patients over 18 years Three months have elapsed since the patient began dialysis No respiratory problems including asthma and respiratory disease
Exclusion criteria:
Having metastatic lung cancer Lack of informed consent
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
N/A
Randomization description
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 Semnan University of Medical Sciences
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Approval date
2019-10-22, 1398/07/30
Ethics committee reference number
IR.SEMUMS.REC.1398.188

Health conditions studied

1

Description of health condition studied
Dialysis
ICD-10 code
R88.0
ICD-10 code description
Cloudy (hemodialysis) (peritoneal) dialysis effluent

Primary outcomes

1

Description
Blood pressure
Timepoint
Before and after dialysis
Method of measurement
Mercury barometer

2

Description
Filtration volume
Timepoint
From the beginning to the end of dialysis
Method of measurement
Liters

3

Description
Arterial blood oxygen levels
Timepoint
From the beginning to the end of dialysis
Method of measurement
Oximeter pulse device

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: Patients undergo dialysis according to the one month protocol with a dialysis machine set up on ultra-filtration modeling.
Category
Treatment - Devices

2

Description
Intervention group 2: Patients according to protocol are dialyses in the second month by simple procedure.
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Kowsar Hospital
Full name of responsible person
Malihe Yarmohammadi
Street address
Street Amin, Semnan
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3345 1336
Email
are20935@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Parviz Kokhaei
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan.
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
P_kokha@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Malihe Yarmohammadi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Nephrology
Street address
Street Amin, Semnan
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3345 1336
Email
are20935@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Malihe Yarmohammadi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Nephrology
Street address
Street Amin, Semnan
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3345 1336
Email
are20935@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Reyhaneh Atashgahian
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Amin Street , Semnan
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3345 1336
Email
are20935@gmail.com

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
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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