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Effect of intermittent normal saline bolus during hemodialysis on adequacy of dialysis

Protocol summary

Summary
1) Objectives: The goal of the study is to investigate effect of intermittent normal saline bolus during hemodialysis on adequacy of dialysis. 2) Design: Our study design is a 4th phase of a randomized, cross over clinical trial. Fifty hemodialysis patients are chosen from Pan Azar Medical Educational Center, Gorgan, based on inclusion and exclusion criteria. They are allocated randomly into intervention and control group. 3) Setting and conduct: At the beginning of the study, we will measure the adequacy of dialysis at the first hemodialysis session. Then, the intervention is implemented on intervention group. After next two hemodialysis sessions, adequacy of dialysis is again measured. Blood clot in the venous chamber and dialyzer will be assessed and graded visually at the end of each hemodialysis session based on a grading table. Then one week is allowed for wash out period after which the groups are crossed over and all the steps will be repeated. 4) Participants: Participants are hemodialysis patients, at least 18 years old, and on maintenance hemodialysis for more than six months (4 hours, and three times per week), from Pan Azar Medical Educational Center, Gorgan. Their access types are Arteriovenous Fistula or Graft. 5) Intervention: Intervention is infusing 100 milliliters of normal saline, 3 times during hemodialysis in addition to following the standard protocol. The control group is dialyzed based on standard protocol. 6) Main outcome measures: The adequacy of dialysis is the primary outcome and the quality of clot formation in the venous chamber and dialyzer is the secondary outcome of the study.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015100324303N1
Registration date: 2015-11-14, 1394/08/23
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-11-14, 1394/08/23
Registrant information
Name
Mitra Shirashiani
Name of organization / entity
Golestan University Of Medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 17 3253 4513
Email address
mitra.shirashiani@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and Innovation of Golestan University of Medical Sciences
Expected recruitment start date
2015-11-06, 1394/08/15
Expected recruitment end date
2015-12-21, 1394/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of intermittent normal saline bolus during hemodialysis on adequacy of dialysis
Public title
Effect of intermittent normal saline bolus during hemodialysis on adequacy of dialysis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Patients with end-stage renal disease treated with maintenance hemodialysis for at least six months; Age above 18 years old; Willingness to participate in the study; On 3 times per week, 4-hours long maintenance hemodialysis; Arteriovenous Fistula or Graft access type; Receives 5000 units of unfractionated heparin during each session of hemodialysis; Hemoglobin concentration 9 to 14 grams per deciliter. Exclusion Criteria: Having acute debilitating disease (cardiovascular, hypertension, cancer and acute infection); Having systolic blood pressure below 90 and above 160 mm Hg.
Age
From 18 years old
Gender
Both
Phase
4
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
50 patients will be allocated randomly (Block Randomization) in two groups (intervention and control).

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Golestan University of Medical Sciences
Street address
Falsafi Educational Campus, Hirkan Boulevard
City
Gorgan
Postal code
4934174515
Approval date
2015-10-04, 1394/07/12
Ethics committee reference number
ir.goums.rec.1394.140

Health conditions studied

1

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

Primary outcomes

1

Description
Adequacy of Hemodialysis (KT/V) and Urea Reduction Ratio (URR)
Timepoint
At first and third session of hemodialysis. After a one-week washout time, again at the first and third session of hemodialysis.
Method of measurement
Pre and post dialysis serum urea and calculation of URR and KT/V using formula recommended by Ministry of Health and Medical Education

Secondary outcomes

1

Description
Clot formation in extracorporeal tubing
Timepoint
At the end of each hemodialysis sessions
Method of measurement
By direct observation and grading

Intervention groups

1

Description
Intervention Group: One Hundred milliliters of normal saline is flushed through the arterial line of extracorporeal tubing three times during the 4-hour period of hemodialysis (once every hour) in addition to following the hemodialysis standard protocal; i.e, receiving 5000 units of unfractionated heparin during hemodialysis. The intervention is for 2 consecutive hemodialysis sessions.
Category
Treatment - Other

2

Description
Control Group: The group is dialyzed based on the standard protocol: Five thousands units of unfractionated heparin are given during the 4-hour period of hemodialysis but no intermittent saline flush.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Panj Azar Medical Educational Center
Full name of responsible person
Mitra Shirashiani
Street address
Panj Azar Street
City
Gorgan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research and Innovation, Golestan University of Medical Sciences
Full name of responsible person
Masoud Khoshnia, MD
Street address
Falsafi Educational Campus, Hirkan Boulevard
City
Gorgan
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 and Innovation, 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
Einollah Mollaei
Position
Master of Nursing, Clinical instructor
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Falsafi Educational Campus, Hirkan Boulevard
City
Gorgan
Postal code
4934174515
Phone
+98 17 3242 6900
Fax
Email
mollaei@goums.ac.ir; einfa15@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Vice Chancellor for Research and Innovation, Golestan University of Medical Sciences
Full name of responsible person
Homeira Khoddam, PhD
Position
PhD in Nursing
Other areas of specialty/work
Street address
Falsafi Educational Campus, Hirkan Boulevard
City
Gorgan
Postal code
49341174515
Phone
+98 17 3242 1660
Fax
Email
khoddam@goums.ac.ir; homeira_khoddam@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
Mitra Shirashiani
Position
Student in Master of Science, Critical Care Nursing
Other areas of specialty/work
Street address
Panj Azar Medical Educational Center, Panj Azar Street
City
Gorgan
Postal code
4917761551
Phone
+98 17 3232 8630
Fax
+98 17 3236 8410
Email
mitra.shirashiani@goums.ac.ir; mitra.shirashiani@yahoo.com; shirashiani.mitra@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
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Study Protocol
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Statistical Analysis Plan
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Informed Consent Form
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Clinical Study Report
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Analytic Code
empty
Data Dictionary
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