Protocol summary

Study aim
The effect of cold dialysis solution on Restless Leg Syndrome in patients undergoing hemodialysis.This study is an easy, cost-free, affordable and unprotected treatment.
Design
In this study 63 patients with restless leg syndrome who are referred to the hemodialysis centers are selected. Participants are randomly divided into intervention and control groups and each participant is assigned a code.
Settings and conduct
This study will be performed on 32 patients in the experimental group and 31 patients in the control group who have inclusion criteria and will randomly be divided into two groups. In this study, patients, researcher and data analyst will be blinded. For one week, all patients will undergo hemodialysis with standardized dialysis solution (37 ° C) then the test group will be treated with a cold hemodialysis solution at 35.5 ° C and control group with a standard temperature (37 ° C) for one month. Patients in both groups will be evaluated before and after intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1. The history of Restless Leg Syndrome during dialysis over the past 2 months. 2. No drug or food use that exacerbate the syndrome during dialysis Exclusion criteria: 1. Patients who will refer for renal transplantation (patients who are linked during the study) 2. Cases of chronic infections, heart failure, chronic pulmonary disease, severe anemia, coronary artery disease and drug abuse
Intervention groups
The effectiveness of dialysis solution at 35.5 ° C on 62 patients (intervention) versus patients who are dialysed with routine fluid solution (control)
Main outcome variables
1- Restless leg syndrom 2- C-Reactive Protein

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170722035232N1
Registration date: 2018-02-10, 1396/11/21
Registration timing: registered_while_recruiting

Last update: 2018-02-10, 1396/11/21
Update count: 0
Registration date
2018-02-10, 1396/11/21
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4422 6989
Email address
kashanie94@medsab.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-14, 1396/11/25
Expected recruitment end date
2018-03-30, 1397/01/10
Actual recruitment start date
2018-01-21, 1396/11/01
Actual recruitment end date
2018-04-04, 1397/01/15
Trial completion date
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Scientific title
The Effects of Cool Dialysate on Restless Leg Syndrome (RLS) in Patients Treated with Hemodialysis
Public title
The Effect of Cool Dialysis on Restless Leg Syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Informed consent to participate in the study Full consciousness and acceptable verbal and auditory ability to answer the questions The patient should not suffer from obvious mental disorder and severe mood - emotional disturbance that prevents effective communication The patient should be in normal neurological and vascular status. Lack of muscular and skeletal disorders debilitating physical activity Lack of ulcer and redness in limbs Patients with chronic renal failure (Patients who have been undergoing hemodialysis for 3 months). Patients who have an arteriovenous fistula, permanent catheter and arterial-venous graft can access their vessels. Patients undergoing hemodialysis three times a week and 4 hours each session. Patients who have had a history of restless leg syndrome during the past 2 months of hemodialysis. Lack of endocrine disorders (such as hypothyroidism and hyperparathyroidism). No history of itchy skin diseases Do not use medicines or foods that they exacerbate the leg syndrome during dialysis, such as: neuroleptics, triangular antidepressants, diphenhydramine, caffeine, alcohol, lithium, beta-blockers, selective serotonin reuptake inhibitors, and serotonin-norepinephrine reuptake inhibitors. Lack of liver problems No medication or treatments that affect on restless leg syndrome during dialysis(oral medicines, complementary medicine, acupuncture and topical softeners). Patients with KT / V ≥1 Patients with hemoglobin 10-11 mg / dL. Lack of febrile illness and chronic infections (pneumonia, cold during hemodialysis). Use of bicarbonate dialysis solution
Exclusion criteria:
Patients with catabolic processes such as: malignancies Diabetic neuropathy Cases of chronic infections, heart failure, chronic pulmonary disease, severe anemia, coronary artery disease and drug abuse
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
  • Data analyser
Sample size
Target sample size: 60
Actual sample size reached: 63
Randomization (investigator's opinion)
Randomized
Randomization description
Samples will be selected using available sampling method and they will take place in intervention and control groups using random allocation permutations blocks.
Blinding (investigator's opinion)
Triple blinded
Blinding description
In this study, Patients in both groups will be blinded by a paper cover that is placed on the dialysis temperature display. The researcher will be blinded by completing the questionnaires by researcher assistant. And data analyzers will be blinded by patient encoding.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Sabzevar University of Medical Sciences
Street address
No. 293, Ibn Yemin No. 41, Ibn Yemin Street
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613876481
Approval date
2016-12-05, 1395/09/15
Ethics committee reference number
IR.Medsab.Rec.1395.92

Health conditions studied

1

Description of health condition studied
Restless Leg Syndrome
ICD-10 code
G25.81
ICD-10 code description
Restless legs syndrome

Primary outcomes

1

Description
Restless leg syndrome
Timepoint
Before and during and after the intervention
Method of measurement
International Restless Legs Syndrome Study Group Questionnaire

Secondary outcomes

1

Description
Measuring C-Reactive Protein (CRP)
Timepoint
Before the intervention and after the intervention
Method of measurement
Use of CRP kits made by Company QCA Spain

Intervention groups

1

Description
Intervention group: The hemodialysis fluid temperature (dialysate) will be adjusted to 35.5 ° C, while the filter type, the ratio of ultrafiltration of the filter, and the speed of the blood flow will not be changed.
Category
Treatment - Other

2

Description
Control group: Hemodialysis fluid temperature will be set at 37 ° C, while the filter type, the ratio of ultrafiltration of the filter, and the speed of the blood flow, and type of device during the study will be fixed.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Vasei hospital
Full name of responsible person
Ehsan Kashani
Street address
Vasei Medical Education Center, Keshavarz Blvd
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617747431
Phone
+98 51 4465 1300
Fax
+98 51 4465 3867
Email
KashaniE94@Medsab.ac.ir

2

Recruitment center
Name of recruitment center
Kashefi Dialysis Center
Full name of responsible person
Ehsan Kashani
Street address
Kashefi Dialysis Center, Kashefi Ave
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617747431
Phone
+98 51 4465 1300
Fax
+98 51 4465 3867
Email
KashaniE94@Medsab.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Mr. Mohsen Koushan
Street address
Pardis of Sabzevar University of Medical Sciences, higher than the Shohada Gomnam, Towhid Boulevard
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913112
Phone
+98 51 4401 8300
Email
mkoushan@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Ehsan Kashani
Position
Master's degree nursing specialist
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Pardis of Sabzevar University of Medical Sciences, above the Yadbood of Shohada Gomnam, Boulevard of Tohid
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913112
Phone
+98 51 4401 8300
Email
KashaniE94@Medsab.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Mr. Dr. Mostafa Rad
Position
Ph.D. Nursing
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Pardis of Sabzevar University of Medical Sciences, above the Yadbood of Shohada Gomnam, Boulevard of Tohid
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913112
Phone
+98 51 4401 8300
Email
mostafarad633@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Ehsan Kashani
Position
Nursing Graduate Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Pardis of Sabzevar University of Medical Sciences, above the Yadbood of Shohada Gomnam, Towhid Boulevard
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913112
Phone
+98 51 4401 8300
Email
KashaniE94@Medsab.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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