Objective: To determine the effect of sodium linear profile - ultrafiltration during hemodialysis on patient tolerance. Study design: crossover. Population of patients admitted to hospital dialysis center in Hamedan besat. Primary criteria: patients 18-75 years old, more than three months Hemodialysis being overweight at 1-4 kg between dialysis, dialysis two or three times a week with a solution of sodium bicarbonate solution, night predialysis blood pressure-lowering drugs are not used. patients with severe anemia (Hb <8) they may not. Main exclusion criteria: severe cardiac and pulmonary disorders , unstable heart muscle death and during dialysis, blood pressure is high enough to lead to discontinuation of dialysis, blood transfusion and other solutions, enhancing the patient's blood volume. analysis is not. samples: 30 patients. intervention or interventions: Case study on any of the sample profile linear sodium - ultrafiltration and routine dialysis will be performed. intervention for each of the randomly dialysis sessions using profiles Linear sodium - ultrafiltration is carried out, and two meeting routine dialysis are. variables five times (before , the first hour, second hour, third hour and 5 minutes after hemodialysis) with both methods of measurement are . primary outcome was a consequence: changes during hemodialysis patients intolerant
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013072814194N1
Registration date:2013-08-26, 1392/06/04
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-08-26, 1392/06/04
Registrant information
Name
Azam Farmani
Name of organization / entity
Hamedan University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0320
Email address
a.farmani@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research & technology, Hamadan University of Medical Sciences
Expected recruitment start date
2013-08-30, 1392/06/08
Expected recruitment end date
2013-10-10, 1392/07/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of linear sodium - ultrafiltration profile on patient tolerance during hemodialysis, in Hemodialysis patients Hamadan's Besat Hospital 1392.
Public title
Effects of profile on patient tolerance during hemodialysis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria for this study included : Patients 18-75 years old ; Over 3 months of hemodialysis; 1-4 kg weight gain between dialysis ; Patients with end-stage renal disease ; Dialysis two or three times a week with a solution of sodium bicarbonate should be done; No night predialysis blood pressure -lowering drugs are not used ; Heart disease - specific diseases such as heart muscle death or have a pacemaker ; With severe anemia (Hb <8) do not ; According to medical diabetic neuropathy (due to orthostatic hypotension in these patients ) are not. Exclusion criteria : Heart and lung disorders; unstable heart muscle death and during dialysis ; Lack of patient cooperation ; Low blood pressure is high enough to lead to discontinuation of dialysis ; if Anti hypertensive drugs in patients on dialysis or had consumed the night before, or before a dialysis session should eat foods high in volume, it is not the meeting to analyze the data; Hypertensive patients after transfusion of blood and other solutions will not increase blood volume analysis .
Age
From 18 years old to 75 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
30
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
Ethic committee of Hamadan university of medical sciences
Street address
Hamadan university of medical sciences, Shahid Fahmideh st, Hamadan
City
Hamadan
Postal code
۶۵۱۷۶۱۹۶۵۱
Approval date
2013-07-27, 1392/05/05
Ethics committee reference number
16/359/1378/پ
Health conditions studied
1
Description of health condition studied
Hemodialysis patient
ICD-10 code
N18.5
ICD-10 code description
End stage kidney disease:on dialysis
Primary outcomes
1
Description
Blood pressure
Timepoint
Before hemodialysis, the first , second, third and fifth minutes after hemodialysis.
Method of measurement
Mercury manometer
2
Description
Muscle Cramp
Timepoint
Before hemodialysis, the first , second, third and fifth minutes after hemodialysis.
Method of measurement
Visual Analog Scale
3
Description
Comfort
Timepoint
After each dialysis session
Method of measurement
Visual Comfort Scale Kolkaba
Secondary outcomes
empty
Intervention groups
1
Description
In this study, the typical profile of linear sodium - ultrafiltration is performed . Purpose of linear sodium dialysate is sodium dialysate during the hours of the first treatment, dialysis, 146 mmol/ l started and then gradually each time reduced dialysis until the last hour to 138 mmol l appears.Purpose of linear ultrafiltration is Two-thirds of the fluid that accumulates between dialysis sessions during the first 2 hours of dialysis treatment and the remaining third in the last 2 hours, the patient's blood is removed from the line by the dialysis machine.
Category
Prevention
2
Description
In the example that was made to the profile , the dialysis procedure is performed . During the procedure, the dialysate sodium concentration of 138 mmol l first and last dialysis treatment on the ultrafiltration rate remains constant and does not change
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Hamadan's Besat Hospital
Full name of responsible person
Azam Farmani, MSc Student in Critical care nursing
Street address
Besat Hospital, Motahari blv, Hamadan
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research & technology, Hamadan university of medical sciences
Full name of responsible person
D.r Haider Toilani
Street address
Hamadan university of medical sciences, Shahid Fahmideh st, Hamadanes
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research & technology, Hamadan 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
Hamadan university of medical sciences
Full name of responsible person
Azam Farmani
Position
MSc Student in Critical care nursing
Other areas of specialty/work
Street address
Hamadan university of medical sciences, Shahid Fahmideh st, Hamadan
City
Hamadan
Postal code
Phone
008372226045
Fax
Email
A.farmani@umsha.ac.ir,Azamfarmani@ymail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamadan university of medical sciences
Full name of responsible person
Azam Farmani
Position
MSc Student in Critical care nursing
Other areas of specialty/work
Street address
Hamadan university of medical sciences, Shahid Fahmideh st, Hamadan
City
Hamadan
Postal code
Phone
008372226045
Fax
Email
A.farmani@umsha.ac.ir,Azamfarmani@ymail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamadan university of medical sciences
Full name of responsible person
Azam Farmani
Position
MSc Student in Critical care nursing
Other areas of specialty/work
Street address
Hamadan university of medical sciences, Shahid Fahmideh st, Hamadans
City
Hamadan
Postal code
Phone
008372226045
Fax
Email
A.farmani@umsha.ac.ir,Azamfarmani@ymail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)