This study is a Triple-blind clinical trial Which aims to determine the effect of cool dialysis on adequacy and Common complications in the Arak center dialysis.The study population consisted of 80 patients with end-stage renal failure in the age range 18 to 80 years,that they are at least three months before to become permanent dialysis And stratified random sampling method based on random numbers table will be in both groups.Intervention will be in two stages. In the first stage one group with a solution of 35 Cº dialysis and the other group with the 36/5 with the solution. In the next step by moving the treatment group than uses from the method of the other groups. every stage consists of 4 sub sessions. blood pressure and body temperature control before and after dialysis and in the first hour and the second and third during dialysis.in the4 and 8 sessions blood sample control before and after dialysis to assess the adequacy of dialysis.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017032633145N1
Registration date:2017-06-24, 1396/04/03
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-06-24, 1396/04/03
Registrant information
Name
Fatemeh Ahmadi
Name of organization / entity
Lorestan University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 66 3312 0140
Email address
fa.ahmadi21@gmail.com
Recruitment status
Recruitment complete
Funding source
Research Deputy of Lorestan University of Medical Sciences
Expected recruitment start date
2017-05-22, 1396/03/01
Expected recruitment end date
2017-08-22, 1396/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of cool dialysate on adequacy and Common complications during hemodialysis in dialysis patients
Public title
The effect of reduction of dialysate temperature in hemodialysis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:patients that are in end stage renal disease and Minimum of three months before participating in the study are hemodialysis;Age over 18 years,None of the blood pressure-lowering drugs on the morning of dialysis are not used;Absence of cardiac disorders such as MI or having a pacemaker; No risk of severe anemia Hb<8 ; No one have cancer; Lack of thyroid disorders (due to temperature changes that may occur). exclusion criteria: Unwillingness to continue treatment, The loss of one of the inclusion criteria, the problem of vascular access, Severe heart disorders such as unstable angina and MI occure during the study; Severe shivering, so that the patient may not be able to continue dialysis;Severe and uncontrollable vomiting.
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Committee, Lorestan university of medical sciences.
Street address
Department of Nursing, School of Nursing and Midwifery, Lorestan University of Medical Sences.
City
Khorramabad
Postal code
381351698
Approval date
2017-05-30, 1396/03/09
Ethics committee reference number
LUMS.REC.1396.262
Health conditions studied
1
Description of health condition studied
hemodialysis
ICD-10 code
Z49.0
ICD-10 code description
Preparatory care for dialysis
Primary outcomes
1
Description
Hemodialysis adequacy
Timepoint
End of 4 Session and of 8 Session
Method of measurement
Measurement of Urea before and after dialysis, according to a formula Daygr DOS 2
2
Description
Common complications during dialysis
Timepoint
During dialysis
Method of measurement
check list
Secondary outcomes
1
Description
blood pressure
Timepoint
Before and after dialysis and in the first, second and third hour dialysis
Method of measurement
Digital manometer cuff
2
Description
Temperatures
Timepoint
Before and after dialysis and in the first, second and third hour dialysis
Method of measurement
Digital thermometer
3
Description
Feeling cold and chills
Timepoint
During dialysis
Method of measurement
During dialysis
Intervention groups
1
Description
Firstly: dialysis for the first group 36.5 and for the second group is set to 35 ° C
Category
Other
2
Description
Secondly: dialysis for the second group 36.5 and for the first group is set to 35 ° C
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Arak dialysis center
Full name of responsible person
Fatemeh Ahmadi, MSc of Nursing Education in Medical Surgical Fieldd
Street address
Lorestan university of medical sciences
City
Khoramabad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Lorestan University of Medical Sciences
Full name of responsible person
Dr. Morovat Taheri-Kalani
Street address
Vice Chancellor for Research, Lorestan University of Medical Sciences
City
Khorramabad
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, Lorestan 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
Lorestan University of Medical Sciences
Full name of responsible person
Fatemeh Ahmadi
Position
MSc of Nursing Education in Medial Surgical Field
Other areas of specialty/work
Street address
Department of Nursing, School of Nursing and Midwifery, Lorestan university of medical sciences.
City
Khorramabad
Postal code
381351698
Phone
+98 66 1620 0140
Fax
+98 66 1620 0140
Email
fa.ahmadi21@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Lorestan University of Medical Sciences
Full name of responsible person
Dr Tahereh Toulabi
Position
Ph.D
Other areas of specialty/work
Street address
Department of Nursing, School of Nursing and Midwifery, Lorestan University of Medical Sciences.
City
Khorramabad
Postal code
381351698
Phone
+98 66 1620 0140
Fax
+98 66 1620 0140
Email
tolabi.t@lums.ac.ir; Toulabi_t@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Lorestan University of Medical Sciences
Full name of responsible person
Fatemeh Ahmadi
Position
MSc of Nursing Education in Medial Surgical Field
Other areas of specialty/work
Street address
Department of Nursing, School of Nursing and Midwifery,Lorestan University of Medical Sciences.
City
Khorramabad
Postal code
381351698
Phone
+98 66 1620 0140
Fax
+98 66 1620 0140
Email
fa.ahmadi21@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)