This is a clinical trial study with randomized controlled design. The purpose of this study is to determine the effect of reducing dialysate temperature on the quality of hemodialysis in dialysis patients. Our samples are included the patients undergoing hemodialysis in 5th Azar hospital who have the inclusion criteria during one month before of study. Simple random sampling technique was employed to select 50 patients that divided into 2 groups of 25 persons. In crossover study, patients are assessed during 24 dialysis sessions; the first group received hemodialysis for 12 sessions using cool dialysate (35.5°C) and the second group is on hemodialysis with standard dialysate temperature (37°C). Then the method of treatment is replaced in two groups for the next 12 sessions. Hemodynamic parameters including SBP, DBP and heart rate (HR) are recorded hourly, before, during and after dialysis. Clinical complaints and treatment interventions related to hypotension are noted. Oral temperature is measured before and immediately after dialysis. For all patients, dialysis adequacy is measured 5 times and Petersburg Sleep Quality Index (PSQI) questionnaire is checked for three stages; before the intervention, before moving groups and at the end of the study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201306268140N2
Registration date:2013-07-14, 1392/04/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-07-14, 1392/04/23
Registrant information
Name
Einollah Mollaei
Name of organization / entity
Golestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 17 1442 6900
Email address
mollaei@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of Research and Technology Golestan University of Medical Sciences
Expected recruitment start date
2013-06-22, 1392/04/01
Expected recruitment end date
2013-08-23, 1392/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of lowering dialysate temperature on the quality of hemodialysis in patients undergoing hemodialysis in 5t Azar hospital
Public title
Effect of lowering dialysate temperature on the quality of hemodialysis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: the samples are included the patients undergoing hemodialysis at 5th Azar hospital having: hypotension in more than 30 percent of dialysis sessions (more than three sessions), during one month before the study; three times dialysis per week with sodium bicarbonate solution; patients did not receive analgesic, anti- hypertensive and anti-spasm during four hours before of dialysis; no history of chronic infections, heart failure, chronic lung disease, drugs / alcohol abuse or require of treatment for mental disorders, severe anemia, coronary artery disease; age more than 18 years old and more than three month's dialysis treatment.
Age
From 18 years old to 75 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)
Single blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Golestan University of Medical Sciences
Street address
Kilometer 2 Gorgan sari -Golestan University of Medical Sciences
City
Gorgan
Postal code
Approval date
2013-03-17, 1391/12/27
Ethics committee reference number
340791122702
Health conditions studied
1
Description of health condition studied
End stage kidney disease
ICD-10 code
N18.5
ICD-10 code description
End stage kidney disease
Primary outcomes
1
Description
dialysis adequacy
Timepoint
5 times
Method of measurement
Laboratory method with URR
2
Description
Sleep Quality
Timepoint
3 times
Method of measurement
Petersburg Sleep Quality Index (PSQI) questionnaire
3
Description
Blood pressure
Timepoint
hourly, before, during and after dialysis
Method of measurement
Blood pressure based on mm Hg, monitoring by Gambro AK96 dialysis machine
4
Description
Temperature
Timepoint
before and immediately after dialysis
Method of measurement
Thermometer
5
Description
Muscle cramps
Timepoint
pre, intra & post dialysis
Method of measurement
checklist
Secondary outcomes
empty
Intervention groups
1
Description
In crossover study, patients are assessed during 24 dialysis sessions; the first group received hemodialysis for 12 sessions using cool dialysate (35.5°C) and the second group is on hemodialysis with standard dialysate temperature (37°C). Then the method of treatment is replaced in two groups for the next 12 sessions.
Each patient gets dialysis once with routine temperature and once with cool dialysate. Patients are assessed during 24 dialysis sessions; the first group receives hemodialysis for 12 sessions using cool dialysate (35.5°C) and the second group is on hemodialysis with standard dialysate temperature (37°C). Then the method of treatment is replaced in two groups for the next 12 sessions. During the study, all the dialysis conditions are maintained the same except temperature of dialysate (37°C or 35.5°). All patients are on hemodialysis using GAMRO AK96 hemodialysis machine.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Dialysis therapy 5t Azar hospital
Full name of responsible person
Street address
City
Gorgan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Golestan University of Medical Sciences
Full name of responsible person
Golalipour Mohammad Jafar
Street address
Kilometer 2 Gorgan Sari , Golestan University of Medical Sciences ,Gorgan
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
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
Mollaei Einollah
Position
Assistant Professor, Department of Medical Surgical Nursing
Other areas of specialty/work
Street address
Kilometer 2 Goran-Sari, Golestan University of Medical Sciences, Gorgan
City
Gorgan
Postal code
Phone
+98 17 1442 6900
Fax
Email
Mollaei@goums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Golestan University of Medical Sciences
Full name of responsible person
Mollaei Einollah
Position
Assistant Professor, Department of Medical Surgical Nursing
Other areas of specialty/work
Street address
Kilometer 2 Goran-Sari, Golestan University of Medical Sciences, Gorgan
City
Gorgan
Postal code
Phone
+98 17 1442 6900
Fax
Email
Mollaei@goums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Golestan University of Medical Sciences
Full name of responsible person
Mollaei Einollah
Position
Assistant Professor, Department of Medical Surgical Nursing
Other areas of specialty/work
Street address
Kilometer 2 Goran-Sari, Golestan University of Medical Sciences, Gorgan
City
Gorgan
Postal code
Phone
+98 17 1442 6900
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)