An investigation of the effect of prescribing erythropoietin on the rate of acute kidney injury following coronary artery bypass graft surgery by on pump method
Title:Investigation of the effect of prescribing erythropoietin (EPO) on the rate of acute kidney injury (AKI) following coronary artery bypass graft surgery (CABG) by on-pump method.
objectives; Introduction of EPO as a prophylaxis factor to reduce AKI following CABG surgery with on-pump.
Design; Randomized، triple blind، placebo controlled.
Setting and conduct; The project nurse will acquire a written informed consent from all patients of the study, then a code is going to be specified to each patient. In the next step, Another nurse will collect the samples from the patients and at the time of the induction of anesthesia, the anesthesia technician randomly (evenly or oddly) will intravenously inject either EPO ( 200 units per Kilogram) or saline. (EPO and saline will be prepared beforehand and will be handed to the anesthesia technician in syringes, so he or she will not be aware of the contents of the syringes) then the data shall be entered into the questionnaires by the student, and at the end, the information on both control and intervention groups will be categorized and utilized for statistical analysis.Major inclusion criteria; Patients among the candidates who have an elective CABG surgery by on pump method.
Major exclusion criteria; AKI prior to the surgery .Intervention; Intravenously inject either EPO or saline,main outcome measures:the blood samples will be collected in order to determine serum creatinine (one sample prior to the surgery as a base, and three samples in24 ,48 ,and72 hours after the surgery to investigate the changes).
General information
Acronym
_
IRCT registration information
IRCT registration number:IRCT2015031617419N2
Registration date:2015-09-02, 1394/06/11
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-09-02, 1394/06/11
Registrant information
Name
Mahmood Hosseinzadeh Maleki
Name of organization / entity
Birjand University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 56 1444 4823
Email address
mahmoodhosseinzadeh@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research، Birjand University of Medical Sciences
Expected recruitment start date
2015-04-04, 1394/01/15
Expected recruitment end date
2015-09-06, 1394/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
An investigation of the effect of prescribing erythropoietin on the rate of acute kidney injury following coronary artery bypass graft surgery by on pump method
Public title
Effect of prescribing erythropoietin on the rate of acute renal failure following open heart surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria; Patients among the candidates who had an elective coronary artery bypass graft surgery by on pump method.
Exclusion criteria; Acute kidney injury prior to the surgery; having erythropoietin prior to coronary artery bypass graft surgery before; uncontrolled blood pressure; erythropoietin allergy; using nephrotoxic drugs before surgery is 3 days.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Birjand University of Medical Sciences
Street address
Birjand University of Medical Sciences .Ghaffari Street. Birjand
City
Birjand
Postal code
0098
Approval date
2015-02-21, 1393/12/02
Ethics committee reference number
1393-12-02
Health conditions studied
1
Description of health condition studied
Acute kidney injury
ICD-10 code
n17
ICD-10 code description
Acute renal failure
Primary outcomes
1
Description
Creatinin
Timepoint
Before Surgery and 24hr,48hr,72hr after surgery
Method of measurement
Serum creatinin was measured using a Prestige 24i (Tokyo Boeki) device and then was measured by Pars Azmoun kits, the scale was mg/dl
Secondary outcomes
1
Description
duration of pump
Timepoint
Intraoperative
Method of measurement
hour
2
Description
the amount of transfused
Timepoint
Intraoperative
Method of measurement
unit
3
Description
Blood pressure
Timepoint
Intraoperative
Method of measurement
mmHg
4
Description
urinary output
Timepoint
Intraoperative
Method of measurement
Catheter and cc
Intervention groups
1
Description
Intervention group: Erythropoietin (PDpoetin10000IU،rh Erythropoietin Alpha)200 units per Kilogram was intravenously injected at the time of the induction of anesthesia
Category
Prevention
2
Description
control group: Saline was intravenously injected at the time of the induction of anesthesia
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Valie-Asr hospital,Birjand
Full name of responsible person
Mahmood Hosseinzadeh maleki.Assistant Professor
Street address
Department of Cardiovascular Surgery,Vali Asr Hospital, Ghafari Street
City
Birjand
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Birjand University of Medical Sciences
Full name of responsible person
Mohammad hasan namaee
Street address
Birjand University of Medical Sciences,Ghafari St.
City
Birjand
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, Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Mahmood Hosseinzadeh maleki
Position
Cardiovascular Surgeon
Other areas of specialty/work
Street address
Birjand University of Medical Sciences,Ghafari Street.