The effect of comparing liner-stepwise sodium and ultrafiltration profiling on hemodialysis adequacy of end stage renal disease patients Undergoing Hemodialysis
This research is a one-blind clinical trial. The aim of this study was to compare the effects of linear and steady-state sodium-polyfractal profiles on hemodialysis in patients with chronic renal failure under hemodialysis. The study population included 32 patients with end stage renal failure aged between 18-80 years old who had undergone continuous hemodialysis for at least three months before being randomly assigned to randomized groups in two groups. This cross-sectional study will be done in two stages. The first group will be three sessions by routine, three sessions with Sodium-Urefiltration Linear Profiles, three sessions with dialysis electrophilic step-step prophylaxis, and the second group will be respectively: Three sessions with Sodium-Urefiltration step prophylaxis, three sessions with Sodium-Ethylphthalate Linear Profiles, three sessions with a routine dialysis procedure. In the third session, each blood sample of BUN and Cr of patients before and after dialysis is collected to assess the adequacy of dialysis.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017080929090N3
Registration date:2017-10-17, 1396/07/25
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-10-17, 1396/07/25
Registrant information
Name
Fariborz Roshangar
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3479 0365
Email address
froshangar@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of Research of Tabriz University of Medical Sciences
Expected recruitment start date
2017-09-06, 1396/06/15
Expected recruitment end date
2017-11-06, 1396/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of comparing liner-stepwise sodium and ultrafiltration profiling on hemodialysis adequacy of end stage renal disease patients Undergoing Hemodialysis
Public title
The effect of comparing liner-stepwise sodium and ultrafiltration profiling on hemodialysis performance
Purpose
Supportive
Inclusion/Exclusion criteria
Absolute consciousness; Kidney disease;
Doing hemodialysis as a routine three times a week;
Doing hemodialysis using sodium-bicarbonate;
conducting dialysis for at least three months;
Age of 18-80;
Hemoglobin higher than 8 mg/deciliter;
Having Arteriovenous fistula or permanent catheter;
Patients whom getting hemodialysis for 4 hours;
Dialysis with Farzinius model c or 4008B with profile;
Not having an acute illness;
Dialysis with antithevalant heparin exclusion criteria;
Unwillingness to continue collaborating;
Patient's agitation and disquiet which causing discontinuing of the hemodialysis;
Acute cardio-pulmonary disorder while getting hemodialysis;
Severe hypertension less than 80 mmhg systolic;
Reduced consciousness;
Performing emergency dialysis;
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
N/A
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences, Faculty of Nursing and Midwifery
Street address
Tabriz - University Street - Research Center
City
Tabriz
Postal code
5138947977
Approval date
2017-07-17, 1396/04/26
Ethics committee reference number
IR.TBZMED.REC.1396.337
Health conditions studied
1
Description of health condition studied
hemodialysis
ICD-10 code
z49.1
ICD-10 code description
Extracorporeal dialysis
Primary outcomes
1
Description
Adequacy of hemodialysis
Timepoint
End of the third session
Method of measurement
Based on urea before and after dialysis (Daiger Das 2 formula)
Secondary outcomes
1
Description
Common complications during dialysis
Timepoint
Each session
Method of measurement
check list
Intervention groups
1
Description
The first group was administered by hemodialyserotomy-modal method by applying linear sodium profiles and ultrafiltration-medialisation by applying sodium stroke profiles and ultrafiltration.
Category
Prevention
2
Description
The second group was hemodialysis, with sodium stroke profile and ultrafiltration-medialysis by applying sodium profiles and ultrafiltration - Hemodialyseroti.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Mehri Hamidi Khasraghi MSc in Internal-Surgery
Street address
Tabriz Imam Reza Hospital-Hemodialysis Department
City
Tabriz
2
Recruitment center
Name of recruitment center
Emam Khomeini Hospital-Oskoo
Full name of responsible person
Mehri Hamidi Khasraghi MSc., Internal Surgery
Street address
Oskoo Imam Khomeini Hospital - Hemodialysis Department
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Fariborz Roshangar
Street address
Tabriz-Faculty of Nursing and Midwifery-Department of Internal-Surgery
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences and Health Services
Full name of responsible person
mehri hamidi khasragi
Position
Master's degree in Internal Surgery Nursing
Other areas of specialty/work
Street address
Tabriz-School of Nursing and Midwifery
City
Tabriz
Postal code
5138947977
Phone
+98 41 3479 6770
Fax
-
Email
mehrihamidi200@gmail.com
Web page address
-
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences and Health Services
Full name of responsible person
Dr. Fariborz Roshangar
Position
Ph.D. in Nursing
Other areas of specialty/work
Street address
Tabriz-Faculty of Nursing and Midwifery
City
Tabriz
Postal code
5138947977
Phone
+98 41 3479 6770
Fax
Email
froshangar@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences and Health Services
Full name of responsible person
Mehri Hamidikhasraghi
Position
Master's degree in Internal Surgery Nursing
Other areas of specialty/work
Street address
Tabriz
City
Tabriz
Postal code
5138947977
Phone
+98 41 3479 6770
Fax
Email
mehrihamidi200@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)