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The effect of the gradual reduction of liquid sodium dialysis hypotension, muscle cramps and plasma sodium levels in hemodialysis patients

Protocol summary

Summary
The purpose of this study was to evaluate the effect of gradual reduction of sodium dialysis fluid on the occurrence of hypotension, muscle cramps and plasma sodium levels in dialysis patients. The relationship between calcium and magnesium with cramp is also assessed and randomized and triple blind clinical trials. Entry: Patients with end-stage renal failure, aged 75-18, who have been undergoing hemodialysis 2-3 times a week for at least two months, and patients who are willing to participate in the project. Exit criteria: Patients who use anti-cramp therapy, patients diagnosed by a physician Blood pressure is not controlled, use of low blood pressure medications in the morning Before dialysis, the presence of a pacemaker is a heart attack such as a heart attack during the last six months and a discharge fraction of less than 30%. The sample size is 106 people. In the first intervention, the patients in the control group were routinized (sodium dialysis solution mEq / l138 in the total duration of dialysis) and the patients in the test group gradually reduced the sodium dialysis solution (starting with 150 mEq / l and reducing it every 15 minutes and then fixing it This concentration will be dialysed for three sessions. Subsequently, both groups undergo dialysis with routine three sessions. Then, using the cross over method, the patients will be replaced in two groups and both groups will dial for three sessions. At this time, patients will be checked for 5 times the blood pressure and muscle cramps are asked and sodium / calcium / magnesium before And after dialysis, it is checked at all stages

General information

Acronym
interventional
IRCT registration information
IRCT registration number: IRCT2017040833295N1
Registration date: 2017-07-27, 1396/05/05
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-07-27, 1396/05/05
Registrant information
Name
Uosra Majidi
Name of organization / entity
Shahroud University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 3239 5054
Email address
uosra1365.majidi@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
State Shahrod University of Medical Sciences
Expected recruitment start date
2017-05-22, 1396/03/01
Expected recruitment end date
2018-01-20, 1396/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of the gradual reduction of liquid sodium dialysis hypotension, muscle cramps and plasma sodium levels in hemodialysis patients
Public title
The effect of the gradual change in liquid sodium dialysis hypotension and cramps and blood sodium dialysis patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria include patients with end-stage renal failure (ESRD); patients aged between 75 and 18, who have been undergoing hemodialysis 2-3 times a week for at least two months; and patients who are willing to participate in the plan. Exclusion criteria include patients who use anti-cramp medication; patients who are not under the control of their physician's blood pressure department; use of medications to lower blood pressure in the morning before dialysis; heart disease, such as heart attack, over a period of six months Recent; patients with discharge fraction of less than 30%; the presence of pacemakers in patients.
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: 106
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
Shahroud University of Medical Sciences
Street address
7th Tir Square, Shahroud University of Medical Sciences
City
Shahroud
Postal code
Approval date
2017-05-24, 1396/03/03
Ethics committee reference number
ir.shmu.rec.1396.35

Health conditions studied

1

Description of health condition studied
kidney disease
ICD-10 code
N19
ICD-10 code description
Unspecified kidney failure

Primary outcomes

1

Description
Blood pressure
Timepoint
Before dialysis, first, second and third and fourth hours of dialysis, the dialysis
Method of measurement
-Br millimeters of mercury using mercury manometer

2

Description
Muscle cramps
Timepoint
Before dialysis, during dialysis, the dialysis
Method of measurement
questionnaire

3

Description
Plasma sodium
Timepoint
Before dialysis, the dialysis
Method of measurement
In terms of mEq per liter by laboratories

Secondary outcomes

1

Description
Hypotension during dialysis
Timepoint
Before dialysis, during dialysis, the dialysis
Method of measurement
-Br millimeters of mercury using mercury manometer

2

Description
Magnesium is the blood
Timepoint
Pre-dialysis and dialysis later
Method of measurement
Mg / dl

3

Description
Calcium of the blood
Timepoint
Pre-dialysis and dialysis later
Method of measurement
Mg / dl

Intervention groups

1

Description
Patients in the control group treated with routine method (sodium dialysis solution 138 meq per liter in total duration of dialysis) for three sessions of dialysis and then both intervention and control groups for a week routine dialysis were (Wash Out) using cross over of patients in the two groups will change and both groups for one week (three days) dialysis will be in both patients twice a week dialysis during the three sessions of dialysis evaluated fall.
Category
Prevention

2

Description
Intervention group patients on hemodialysis with the gradual reduction of sodium dialysis solution (starting with 150 meq per liter and cut it every 15 minutes, and then maintain this concentration) for one week (three days) will be dialysis. Both intervention and control groups for a week routine dialysis were (Wash Out) then using a cross over of patients in both groups will change and both groups for one week (three days) Dialysis and will both groups of patients who are on dialysis twice a week during the three sessions of dialysis evaluated.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahrood Hospital and research of Imam Hussein (AS)
Full name of responsible person
Doctor Hossein Ebrahimi
Street address
Imam Hossein Hospital, Imam Hossein Square, Shahrood
City
Shahrood

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahrood University of Medical Sciences
Full name of responsible person
Doctor Hossein Ebrahimi
Street address
Hafte-Tir Square
City
Shahrood
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahrood 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
Shahrood University of Medical Sciences
Full name of responsible person
Uosra Majidi
Position
Graduate student care
Other areas of specialty/work
Street address
Kosar hospital
City
Semnan
Postal code
Phone
+98 23 31420
Fax
Email
uosra1365.majidi@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahrood University of Medical Sciences
Full name of responsible person
Ali Abbasi
Position
Master of Internal and Surgery
Other areas of specialty/work
Street address
Hafte-Tir Square
City
Shahrood
Postal code
Phone
+98 23 3239 5054
Fax
Email
abbasi_msn@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahrood University of Medical Sciences
Full name of responsible person
Uosra Majidi
Position
Graduate student Care
Other areas of specialty/work
Street address
Kosar hospital
City
Semnan
Postal code
Phone
+98 23 31420
Fax
Email
uosra1365.majidi@gmail.com
Web page address

Sharing plan

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