This research is a clinical trial which will be performed in cross-over and single-blind method. The purpose of this research is to determine the effect of sodium and temperature profiles on blood pressure fluctuations during hemodialysis. The samples are hemodialysis patients in Imam Hossein Shahrood, Iran . inclusion criteria are age of 18-75, hemodialysis for more than six months and three times a week with a solution of sodium bicarbonate. The patients have systolic blood pressure <100 mm Hg before starting dialysis. and patients who receive , anti-hypertensive and blood transfusion are not included. The samples, 80 patients, are selected by accessible sampling method, and randomly allocated to four groups of members. In each of the groups, one specific protocol for hemodialysis is performed. 1: Standard sodium dialysate and standard temperature. 2: Standard sodium dialysate and low temperature. 3: line sodium dialysate and Standard temperature. 4 :High sodium and low temperature. In every session, blood pressure is monitored five times. Any muscle cramps, nausea, vomiting and headache are recorded. Fresenius hemodialysis machine are used for all samples.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013050613248N1
Registration date:2013-11-30, 1392/09/09
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-11-30, 1392/09/09
Registrant information
Name
Marzieh Hossein Saedee
Name of organization / entity
Tehran medical Branch of Islamic Azad university
Country
Iran (Islamic Republic of)
Phone
+98 23 2524 3517
Email address
parisan.saeidi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Tehran medical Branch of Islamic Azad University
Expected recruitment start date
2013-11-01, 1392/08/10
Expected recruitment end date
2014-02-01, 1392/11/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of sodium profile and temperature on blood pressure fluctuations of patients in hemodialysis section of Imam Hossein hospital in Shahrood ،2013
Public title
The effect of sodium profile change and temperature on preventing from the blood pressure fluctuations during hemodialysis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria :the patients are between 18t-75 years old؛ they have Chronic Kidney disease ؛ patients must have medical records in hospital and three sessions dialysis weekly؛ Exclusion criteria: The patients with specific infections disease history؛ Acquired immune deficiency syndrome - coagulopathy- poor nutrition and patients who are using antihypertensive drugs and eating large meals plus patients who have received blood products on hemodialysis sessions؛ The patients with chronic diseases who have hypertension during hemodialysis have also been excluded.
Age
From 18 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahrood University of Medical Sciences
Street address
university of medical science , Haft-e-tir square , Shahrood
City
shahrood
Postal code
3614773955
Approval date
2013-05-26, 1392/03/05
Ethics committee reference number
920/04
Health conditions studied
1
Description of health condition studied
Chronic kidney desease
ICD-10 code
N18.5
ICD-10 code description
End stage kidney disease
Primary outcomes
1
Description
BLOOD PRESSURE
Timepoint
Before, during and after the study
Method of measurement
mm/hg
Secondary outcomes
empty
Intervention groups
1
Description
For each group in this research, four different hemodialysis protocols are implemented. These protocols are as follows: Protocol A:Standard Sodium Dialysate and Standard Temprature. Protocol B: Standard Sodium Dialysate and low temprature. Protocol C: Linear Sodium Dialysate (150 - 138 mEq/L) andStandard temprature. Protocol D: Linear Sodium Dialysate (150 mEq/L-138) and low temprature. Linear Sodium Dialysate: In the first hour of the dialysis the amount of Sodium dialysate is 150mEq/L, then is gradually decreasing in per hour. In the last hour of the dialysis, it reaches 138mEq/L. The low temprature is 35 ° C and standard temprature is 37° C.For any patients, three hemodialysis sessions are considered for each of the protocols.Standard sodium dialysate: During the 3-hour dialysis session, dialysate sodium of 140 mEq /L is maintained. For group A, protocols, ADBC run respectively
Category
Prevention
2
Description
For Group B, protocols, BACD run respectively.
Category
Prevention
3
Description
For Group C, protocols, CBDA run respectively
Category
Prevention
4
Description
For Group D, protocols, DCAB run respectively.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein Hospital, Shahrood
Full name of responsible person
Marzieh Hossein Saedee
Street address
Hemodyalysis of Imam Hossein Hospital, Shahrood
City
Dameghan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran medical Branch of Islamic azad university
Full name of responsible person
Marzieh hossein Saedee Graduate student of nursing
Street address
Tehran medical Branch of Islamic azad university , Khagh ani Ave, shariati st, Tehran
City
Damghan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran medical Branch of Islamic azad university
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
Tehran medical Branch of Islamic azad university
Full name of responsible person
Marzieh hossein Saedee
Position
Graduate student of nursing
Other areas of specialty/work
Street address
Tehran medical Branch of Islamic azad university , Khagh ani Ave, shariati st, Tehran
City
DAMGHAN
Postal code
3671794751
Phone
+98 23 2524 3517
Fax
Email
parisan.saeidi@ yahoo.comr
Web page address
www.iautmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran medical Branch of Islamic Azad universiyu
Full name of responsible person
Marzieh Hossein Saedee
Position
Graduate student of nursing
Other areas of specialty/work
Street address
Tehran medical Branch of Ialamic azad university ، khagh ani Ave,Shariati St , tehran.
City
DAMGHAN
Postal code
3671794751
Phone
+98 23 2524 3517
Fax
No fax
Email
parisan.saeidi@yahoo.com
Web page address
www.iautmi.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran medical Branch of Islamic Azad university
Full name of responsible person
Marzieh hossein Saedee
Position
Graduate student of nursing
Other areas of specialty/work
Street address
Tehran medical Branch of Islamic azad university , khaghani Ave , Shariati st , Tehran.
City
DAMGHAN
Postal code
3671794751
Phone
+98 23 2524 3517
Fax
No Fax
Email
parisan.saeidi @ yahoo.com
Web page address
www.iautmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)