End Stage Renal Disease (ESRD) is the last stage of chronic renal failure requiring replacement therapy with dialysis or a kidney transplant. Currently, 14,000 people in Iran are hemodialysis, the most common cause of death in patients is cardiovascular disorders, including cardiac arrhythmias such as Atrial Fibrillation (AF) and Ventricular Premature Contraction (PVC). Hemodialysis due to changes in electrolyte imbalance plays a role in these arrhythmias. The effect of dialysis solutions, with different concentrations of potassium, causing cardiac arrhythmias during hemodialysis in patients with advanced renal failure. In this study, we recruited a total of 90 patients who have passed at least 2 weeks of hemodialysis with no history of heart failure, myocardial infarction and cardiac pacemaker. They were randomly divided into control and experimental groups. The control group receive a dialysis solution of potassium 2mmol/lit and the experimental group receive a dialysis solution of potassium 3mmol/lit and Halter monitoring was performed during hemodialysis. Halter monitoring results will be analyzed by cardiologists and type and number of arrhythmias was statistically comparable in both groups.
General information
Acronym
ESRD,AF,PVC,CKD
IRCT registration information
IRCT registration number:IRCT201104206241N1
Registration date:2012-01-08, 1390/10/18
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-01-08, 1390/10/18
Registrant information
Name
Masihollah Shakeri
Name of organization / entity
Ahvaz University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 917 792 1924
Email address
shakeri.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Ahvaz University of Medical Sciences
Expected recruitment start date
2011-06-21, 1390/03/31
Expected recruitment end date
2011-10-22, 1390/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The evaluation of different dialysate potassium concentration on cardiac arrythmia during hemodialysis in End Stage Renal Disease (ESRD) patients
Public title
Evaluation of cardiac arrhythmia in End Stage Renal Disease (ESRD) patient during hemodialysis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: All of ESRD patients who have started hemodialysis since two weeks ago. Exclusion criteria: a) old M.I with Q wave in ECG or acute M.I during hemodialysis; b) non sinusoidal rhythm and multiple PVC; c) with heart pace maker; d) the consumption of digital drug and chemotherapy medication in recently 2 weeks; e) heart EF<40% and severe heart valvular diseases in recently 3 months; f) non functional catheter or fistula or inadequate blood supply during hemodialysis.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ahvaz University of Medical Sciences
Street address
University City, Ahvaz
City
Ahvaz
Postal code
Approval date
2011-04-16, 1390/01/27
Ethics committee reference number
ETH-130
Health conditions studied
1
Description of health condition studied
End Stage Renal Disease
ICD-10 code
N18.0
ICD-10 code description
End Stage Renal Disease
Primary outcomes
1
Description
Cardiac arrhythmias during hemodialysis
Timepoint
During hemodialysis
Method of measurement
Hultermonitoring
Secondary outcomes
1
Description
Potassium
Timepoint
Bfore and After hemodialysis
Method of measurement
Blood sample
2
Description
Calcium
Timepoint
Bfore and After hemodialysis
Method of measurement
Blood sample
3
Description
PH of blood
Timepoint
Bfore and After hemodialysis
Method of measurement
Blood sample
Intervention groups
1
Description
Hemodialysis in control group with dialysate 2mmol/Eq
Category
Treatment - Other
2
Description
Experimental group with dialysate 3mmol/Eq
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Khomaini hospital
Full name of responsible person
Masihollah Shakeri
Street address
Emam Khomaini hospital
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
vice chancellor for research, Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Mostafa Feghi
Street address
University City
City
Ahvaz
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, Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Masihollah Shakeri
Position
Resident of Internal Medicine
Other areas of specialty/work
Street address
Emam khomaini hospital
City
Ahvaz
Postal code
Phone
+98 917 792 1924
Fax
Email
dr_shakerim@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Saied Saifollah Beladi Mousavi
Position
Assistant professor
Other areas of specialty/work
Street address
Emam Khomaini hospital
City
Ahvaz
Postal code
Phone
+98 916 306 8063
Fax
Email
beladimusavi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Masihollah Shakeri
Position
Resident
Other areas of specialty/work
Street address
Emam Khomaini hospital
City
Ahvaz
Postal code
Phone
Fax
Email
dr_shakerim@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)