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Comparison of the effect of (low flow) and (high flow) filters on fatigue and sleep quality of patients undergoing hemodialysis treatment

Protocol summary

Study aim
Determine and Comparison of the effect of (low flow) and (high flow) filters on fatigue and sleep quality of patients undergoing hemodialysis treatment
Design
This research is a clinical trial study with a control group, with parallel groups, one score, randomized, on 32 patients. The lottery method is used for randomization.
Settings and conduct
The environment of this research is dialysis centers covered by Zabol University of Medical Sciences. Participants are randomly assigned to two groups. A score means that the subjects do not know which group they are in.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Informed consent, suffering from end-stage kidney disease, at least 6 months have passed since the start of hemodialysis treatment, dialysis three times a week and four hours each time, age more than 18 years, maximum age 60 years... Temporary exclusion criteria: Blood pressure more than 140/90 and less than 100/60 mm Hg at the start of hemodialysis, body temperature more than 38 and less than 36 degrees Celsius at the start of hemodialysis, dialysis interruption for any reason during 3 dialysis sessions, agitation and Restlessness, severe and uncontrollable vomiting during hemodialysis, changes in diet, taking drugs that affect fatigue and sleep.
Intervention groups
In both groups, before each intervention, the fatigue intensity and sleep quality questionnaires are completed. Group A is subjected to hemodialysis by standard method using low flux filter (PES13), for 6 sessions of 4 hours, during two weeks. Group B will undergo hemodialysis for 6 sessions of 4 hours during two weeks using high flux filter (PES130). Questionnaires will be completed by both groups on the day after the third meeting. Questionnaires will be completed by both groups on the day after the sixth session.
Main outcome variables
Fatigue; Sleep quality; Adequacy of dialysis

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240612062108N1
Registration date: 2024-06-19, 1403/03/30
Registration timing: prospective

Last update: 2024-06-19, 1403/03/30
Update count: 0
Registration date
2024-06-19, 1403/03/30
Registrant information
Name
Mehrnoosh Sanadgol
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 933 578 2257
Email address
mehrnoosh.sanadgol2000@zbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-13, 1403/04/23
Expected recruitment end date
2025-03-13, 1403/12/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of (low flow) and (high flow) filters on fatigue and sleep quality of patients undergoing hemodialysis treatment
Public title
Comparison of the effect of (low flow) and (high flow) filters on fatigue and sleep quality of patients undergoing hemodialysis treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Informed consent and the ability to participate in the implementation of the plan Suffering from end-stage kidney disease At least 6 months have passed since the start of hemodialysis treatment Dialysis three times a week and four hours each time Age more than 18 years Maximum age of 60 years Absence of cardiopulmonary disease and other acute diseases Does not have a history of mental disorders (neurological diseases for which the patient is under the treatment of a neurologist) No stressful events in the last one month (any event that increases mental and emotional pressure on the patient, such as divorce, death of close relatives, loss of job, migration, and severe accident) Having arteriovenous fistula
Exclusion criteria:
Withdrawal of patients from participating in the study Subjecting the patient to other treatments (meaning kidney transplant or hospitalization of the patient for any reason) Hepatitis, acquired immunodeficiency syndrome, septicemia and chemotherapy Death
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 32
Randomization (investigator's opinion)
Randomized
Randomization description
In this research, first, a list of patients who meet the research inclusion criteria will be prepared, and then by random allocation, the first person selected will be in the intervention group and the second person will be in the control group. It will be continued that all research samples are in one of two intervention or control groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
This study will be conducted as a blind controlled clinical trial (meaning that the subjects do not know which of the groups they are in).
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of Zabol University of Medical Sciences
Street address
University Research Assistant, University of Medical Sciences Educational Complex, Shahid Rajaei Ave., Zabol Town
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
98616615881
Approval date
2024-06-12, 1403/03/23
Ethics committee reference number
IR.ZBMU.REC.1403.020

Health conditions studied

1

Description of health condition studied
Hemodialysis
ICD-10 code
Z49.1
ICD-10 code description
Extracorporeal dialysis

Primary outcomes

1

Description
Fatigue
Timepoint
Before the intervention and on the day after the third intervention session and on the day after the sixth intervention session
Method of measurement
Multidimensional Fatigue Inventory_20

2

Description
Sleep quality
Timepoint
Before the intervention and on the day after the third intervention session and on the day after the sixth intervention session
Method of measurement
Pittsburgh Sleep Quality Index

Secondary outcomes

1

Description
Adequacy of dialysis
Timepoint
After each hemodialysis session
Method of measurement
By means of blood test and formula of single rate of Daugirdas

Intervention groups

1

Description
Intervention group: using high flux strainer (PES130) and with blood flow of 250 and dialysis fluid flow of 700 ml/min for 6 sessions of 4 hours, they undergo hemodialysis during two weeks.
Category
Treatment - Devices

2

Description
Control group: They will be subjected to hemodialysis in the standard and routine method in which the dialysis fluid flow is 500 and the blood flow is 250 ml/min using a low flux filter (PES13) for 6 sessions of 4 hours, during two weeks.
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Center for Special Patients, Zaboll
Full name of responsible person
Dr. Mohammad Ali Drohi
Street address
Between 16 and 17 Motahari., Motahari Ave., Zabol Town
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
9861673137
Phone
+98 54 3222 6069
Fax
+98 54 3222 6069
Email
emam-hospital-zabol@zbmu.ac.ir

2

Recruitment center
Name of recruitment center
Seyed al-Shohada Zahak Hospital
Full name of responsible person
Dr. Nakh Zari
Street address
22 Bahman Boulevard., Imam Khomeini Boulevard., Zahak Town
City
Zahak
Province
Sistan-va-Balouchestan
Postal code
9871713111
Phone
+98 54 3322 2614
Fax
+98 54 3322 2615
Email
info@zbmu.ac.ir

3

Recruitment center
Name of recruitment center
Shahada Hirmand Hospital
Full name of responsible person
Dr. Behzad Sediq
Street address
Near to Mukhtar village., End of South Imam Khomeini Ave., Hirmand township., Zabol Town
City
Hirmand
Province
Sistan-va-Balouchestan
Postal code
9861663335
Phone
+98 54 3262 3243
Fax
+98 54 3262 3245
Email
hirmandhospital@zbmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zabol University of Medical Sciences
Full name of responsible person
Dr. Khadijah Rezaei Kikhaei
Street address
University Research Assistant, University of Medical Sciences Educational Complex, Shahid Rajaei Ave., Zabol Town
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
98616615881
Phone
+98 54 3223 0768
Fax
+98 54 3223 0770
Email
Research@zbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zabol University of Medical Sciences
Proportion provided by this source
20
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
Zabol University of Medical Sciences
Full name of responsible person
Mehrnoosh Sanadgol
Position
Master's student of special nursing care
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 89, Ferdowsi Four., Ferdowsi Ave., Zabol Town
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
9861749988
Phone
+98 54 3222 4702
Email
mehrnoosh.sanadgol@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zabol University of Medical Sciences
Full name of responsible person
Dr. Hossein Shahdadi
Position
University faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Near to the registry office, 11 Ferdowsi Ave., Zabol Town
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
9861734184
Phone
+98 54 3222 3947
Email
zb5950@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Zabol University of Medical Sciences
Full name of responsible person
Mehrnoosh Sanadgol
Position
Master's student of special nursing care
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 89, Ferdowsi Four., Ferdowsi Ave., Zabol Town
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
9861749988
Phone
+98 54 3222 4702
Email
mehrnoosh.sanadgol@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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