Protocol summary

Summary
1)objectives:The effect of different potassium and bicarbonate levels of hemodialysis solutions on QTc interval of patients under chronic hemodialysis. 2)Design:Single blind randomized controlled trial. 3)Setting and conduct:35 patients older than 18 years with a history of hemodialysis for more than 6 months were selected.Each patient will be on dialysis for 4 hours with one of the following solutions: Solution 1: K = 2, HCO3 = 24, Na = 140, Ca = 1.25 Solution 2: K = 2, HCO3 = 28, Na = 140, Ca = 1.25 Solution 3: K = 3, HCO3 = 24, Na = 140, Ca = 1.25 Solution 4: K = 3, HCO3 = 28, Na = 140, Ca = 1.25  Before and one hour after hemodialysis ECG will be taken and a cardiologist who is unaware of dialysate will measure QTc and changes will be registered.Venous gas and electrolyte concentrations before initiation of dialysis will be registered. 4)Participants:chronic kidney disease requiring chronic hemodialysis. Inclusion criteria:All chronic kidney disease requiring chronic hemodialysis. Exclusion criteria:Any arrhythmia; Ejection Fraction under 40%; Use of anti arrhythmic drugs other than beta-blockers; The occurrence of hypotension during dialysis; Previous coronary heart disease. 5)Interventions:change of potassium and bicarbonate levels of hemodialysis solutions. 6)main outcome measures:QTc interval changes.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013021011194N3
Registration date: 2014-09-23, 1393/07/01
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-09-23, 1393/07/01
Registrant information
Name
Foroogh Sabzghabaei
Name of organization / entity
Tehran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 8214 1600
Email address
f-sabzghabaei@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research,Iran uneversity of medical science 5th floor, iran university of medical science, junction of sheikh fazlollah & chamran highway, hemmat highway tehran
Expected recruitment start date
2014-08-01, 1393/05/10
Expected recruitment end date
2014-10-01, 1393/07/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of different potassium and bicarbonate levels of hemodialysis solutions on QTc interval of patients under chronic hemodialysis
Public title
The effect of different potassium and bicarbonate levels of hemodialysis solutions on QTc interval of patients under chronic hemodialysis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:All chronic kidney disease requiring chronic hemodialysis. Exclusion criteria:Any arrhythmia; Ejection Fraction under 40%; Use of anti arrhythmic drugs other than beta-blockers; The occurrence of hypotension during dialysis; Previous coronary heart disease.  
Age
From 18 years old to 75 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 35
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features

Secondary Ids

1

Registry name
no
Secondary trial Id
no
Registration date
empty

Ethics committees

1

Ethics committee
Name of ethics committee
ٍEthic commitee of Iran university of medical science
Street address
5th floor, Iran university of medical science, junction of Sheikh Fazlollah & Chamran highway,Hemmat Highway
City
Tehran
Postal code
Approval date
2014-07-28, 1393/05/06
Ethics committee reference number
105/2128/د/93

Health conditions studied

1

Description of health condition studied
End stage kidney disease
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5

Primary outcomes

1

Description
QT interval
Timepoint
Before and after dialysis
Method of measurement
bazzet formula

Secondary outcomes

empty

Intervention groups

1

Description
changing potassium and bicarbonate levels of hemodialysis solutions in intervention group -No control group
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Firoozgar Hospital
Full name of responsible person
Dr. Foroogh Sabzghabaei
Street address
Behafarin St., Karimkhan Zand Ave., Valiasr Sq
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research,Iran uneversity of medical science
Full name of responsible person
dr.Morteza Naserbakht
Street address
5th floor, Iran university of medical science, junction of Sheikh Fazlollah & Chamran highway, Hemmat highway
City
Tehran
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,Iran uneversity of medical science
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
Iran University of Medical Science
Full name of responsible person
Dr. Foroogh Sabzghabaei
Position
Nephrologist/ assistant professor
Other areas of specialty/work
Street address
Behafarin St., Karimkhan Zand Ave., Valiasr Sq.
City
Tehran
Postal code
Phone
+98 212182141600
Fax
Email
f-sabzghabaei@tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Science
Full name of responsible person
Dr. Foroogh Sabzghabaei
Position
nephrologist/ assistant professor
Other areas of specialty/work
Street address
Behafarin St., Karimkhan Zand Ave., Valiasr Sq.
City
Tehran
Postal code
Phone
+98 21 8214 1600
Fax
Email
f-sabzghabaei@tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Science
Full name of responsible person
Dr Foroogh Sabzghabaei
Position
Nephrologist/ assistant professor
Other areas of specialty/work
Street address
Behafarin St.,
City
Tehran
Postal code
Phone
+98 21 8214 1600
Fax
Email
f-sabzghabaei@tums.ac.ir
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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