The effect of ultra filtration adjustment based on dry weight calculation by measuring serum sodium pre- dialysis on some of hemodialysis complications
The aim of this clinical trial study is to determine the effect of ultrafiltration adjustment based on the dry weight calculation by measuring serum sodium pre-dialysis on some complications during hemodialysis.
Population and sample: The study population will be patients undergoing hemodialysis who refer to 5th Azar hospital at the time of the study. 50 samples will be selected through convenience sampling. Then 25 patients will be allocated in intervention and control group randomly. Inclusion criteria include of a history of dialysis for at least one year; lack of diseases that cause fluid imbalance and exclusion criteria include disruption of blood flow through the fistula during the study.
In the intervention group, the dry weight will be calculated using blood sodium before dialysis and then ultrafiltration set based on dry weight. In control group dry weight will be calculated in routine way and then hemodialysis complications will be measured in both groups. At the end of study two groups will be compared in terms of complications during hemodialysis.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015042318649N2
Registration date:2015-09-09, 1394/06/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-09-09, 1394/06/18
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
Golestan University of Medical Sciences, Deputy of Research and Technology
Expected recruitment start date
2015-08-23, 1394/06/01
Expected recruitment end date
2015-11-21, 1394/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of ultra filtration adjustment based on dry weight calculation by measuring serum sodium pre- dialysis on some of hemodialysis complications
Public title
The impact of dry weight calculation by measuring serum sodium pre- dialysis on some of hemodialysis complications
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: history of dialysis more than one year; Age of 18-65 years; be able to communicate verbally; lack of syndrome of inappropriate antidiuretic hormone secretion and diabetes insipidus; lack of human immunodeficiency virus infection; lack of mechanical ventilation; do not have heart and liver failure; lack of an overactive adrenal gland; do not use serotonin inhibitor drugs; do not use anti-spasmodic and anti-hypertensive drugs four hours before of dialysis.
Exclusion criteria: The patient's unwillingness to continue for cooperating during the study; disruption of blood flow through the fistula.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
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 Golestan University of Medical Sciences
Street address
Falsafi Educational Campus, Shastkola Road
City
Gorgan
Postal code
Approval date
2015-05-22, 1394/03/01
Ethics committee reference number
IR.goums.rec.1394.8
Health conditions studied
1
Description of health condition studied
Renal failure
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5
Primary outcomes
1
Description
Blood pressure disorders
Timepoint
At one hours interval during dialysis
Method of measurement
Blood pressure is measured using a sphygmomanometer
2
Description
Muscle cramps
Timepoint
At one hours interval during dialysis
Method of measurement
Using check list
3
Description
Nausea and vomiting
Timepoint
At one hours interval during dialysis
Method of measurement
Using check list
4
Description
Fatigue
Timepoint
At the end of dialysis
Method of measurement
Using Visual scale
Secondary outcomes
empty
Intervention groups
1
Description
In the intervention group:
The blood sodium levels will be measured pre - dialysis to calculate patients' dry weight and then ultrafiltration will be set based on dry weight and dialysis will be done for 12 weeks.
Category
Treatment - Other
2
Description
In the control group: Dry weight will be determined in routine way and accordingly the ultrafiltration rate will be adjusted and patient will be dialysis for 12 weeks.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
5 Azar medical and educational center
Full name of responsible person
Sara Saadatmand
Street address
5 Azar Street
City
Gorgan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Golestan University of Medical Sciences, Deputy of research and technology
Full name of responsible person
Masoud Khosh Nia
Street address
Falsafi Educational Campus, Shastkola Road
City
Gorgan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Golestan University of Medical Sciences, Deputy of research and technology
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
Golestan University of Medical Sciences
Full name of responsible person
Sara Saadatmand
Position
Student in Master of Science in Critical Care Nursing
Other areas of specialty/work
Street address
Falsafi Educational Campus, Shastkola Road
City
Gorgan
Postal code
Phone
+98 17 3242 6900
Fax
Email
saadatmand.sara61@gmil.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Golestan University of Medical Sciences
Full name of responsible person
Khadijeh Yazdi
Position
Assistance Professor of Medical Surgical Nursing
Other areas of specialty/work
Street address
Falsafi Educational Campus, Shastkola Road
City
Gorgan
Postal code
Phone
+98 17 3242 6900
Fax
Email
yazdikh@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Golestan University of Medical Sciences
Full name of responsible person
Sara Saadatmand
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)