Evaluating the effect of Acetazolamide on the prevention of post-operative Acute Kidney Injury (AKI) following Coronary Artery Bypass Grafting (CABG) surgery
Evaluating the effect of acetazolamide on the prevention of acute kidney injury following coronary artery bypass grafting surgery
Design
This randomized controlled trial, in phase 3 on 70 patients candidates for coronary artery bypass grafting surgery who referred to Masih Daneshvari and modaress Hospital in Tehran by block randomization method divided into intervention and control groups, enrolled in the study.
Settings and conduct
Place of study; Dr Masih Daneshvari and modarres Hospitals, How to do the study; 70 patients who are candidates for coronary artery bypass grafting surgery randomly divided into intervention or control groups by block randomization method
Participants/Inclusion and exclusion criteria
Inclusion criteria; Patients who refer to Masih Daneshvari and Modaress Hospital for coronary artery bypass grafting surgery (CABG)
Exclusion criteria; Any allergies to any of the compounds in acetazolamide tablet and sulfonamide compounds
Liver failure (stage II, III or liver enzymes more than 3 times)
Chronic renal failure (Stage IV & V), clearance creatinine less than 30 ml / min, and anorexia
Chronic heart failure (Ejection Fraction <30)
Emergency CABG
Hypokalemia (potassium less than 3.3 mmol / L), hyponatremia (sodium less than 135 mmol / L)
Gout attack
Intervention groups
Drug group; Patients receive 500 mg acetazolamide orally on the morning of surgery
Control group; This group does not receive acetazolamide.
Main outcome variables
Incidence of acute kidney injury, Increasing of Creatinine biomarker and urine output
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151227025726N21
Registration date:2020-09-17, 1399/06/27
Registration timing:registered_while_recruiting
Last update:2020-09-17, 1399/06/27
Update count:0
Registration date
2020-09-17, 1399/06/27
Registrant information
Name
Farzaneh Dastan
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 270 5933
Email address
f_dastan@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-19, 1398/12/29
Expected recruitment end date
2020-10-21, 1399/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of Acetazolamide on the prevention of post-operative Acute Kidney Injury (AKI) following Coronary Artery Bypass Grafting (CABG) surgery
Public title
Evaluating the effect of Acetazolamide on the prevention of post-operative Acute Kidney Injury following Coronary Artery Bypass Grafting surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
It will be performed on patients who refer to Masih Daneshvari and Modares Hospital for Coronary Artery Bypass Surgery (CABG).
Exclusion criteria:
History of any allergies to any of the compounds in acetazolamide tablets and sulfonamide compounds
Liver failure (stage II, III or liver enzymes more than 3 times)
Chronic renal failure (Stage IV & V CKD) or patients with serum creatinine less than 30 ml / min, anorexia
Chronic heart failure (Ejection Fraction <30)
Patients undergoing CABG surgery for emergency reasons.
Hypokalemia (potassium less than 3.3 mmol / L), hyponatremia (sodium less than 135 mmol / L)
Gout attack
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization method was used in this study by online website;(www.sealedenvelope.com/simple-randomiser/v1/lists). Fourteen blocks including 5 patients generated with this online website. In each block, patients will be assigned to acetazolamide or control group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Medical Sciences ,Pharmacy Faculty
Street address
No. 2660, Vali-e Asr St., Niyayesh Junction, Tehran
City
Tehran
Province
Tehran
Postal code
141556153
Approval date
2020-07-25, 1399/05/04
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1399.146
Health conditions studied
1
Description of health condition studied
Acute kidney injury
ICD-10 code
N99.9
ICD-10 code description
Acute kidney injury
Primary outcomes
1
Description
Creatinine plasma LEVEL
Timepoint
Before surgery and daily for up to seven days
Method of measurement
ELISA
2
Description
Volume of urine
Timepoint
Before the operation until the patient is in the intensive care unit
Method of measurement
The amount of urine in the urine bag
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients in the acetazolamide group are treated with acetazolamide at a dose of 500 mg once daily on the morning of surgery.
Category
Treatment - Drugs
2
Description
Control group: Patients in the control group receive routine treatment on the day of surgery.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Masih Daneshvari Hospital
Full name of responsible person
Farzaneh Dastan
Street address
Dr. Masih Daneshvari Hospital, Daar-Abad, Niavaran
City
Tehran
Province
Tehran
Postal code
19569-44413
Phone
+98 21 2712 3000
Fax
+98 21 2610 9490
Email
F_dastan@sbmu.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Nima Naderi
Street address
Vali_e Asr Ave., Niayesh junction
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2712 2265
Email
Mpd@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Golnaz Afzal
Position
Resident of Clinical pharmacy
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Niayesh Highway, Valiasr Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1991953381
Phone
+98 21 8820 0118
Fax
Email
Pr_pharmacy@sbmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Farzaneh Dastan
Position
Clinical Pharmacy (Pharmacotherapy) specialist, assistant professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Niayesh Highway, Valiasr Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1991953381
Phone
+98 21 8820 0118
Fax
Email
F_dastan@sbmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Golnaz Afzal
Position
Resident of Clinical Pharmacy
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Niayesh Highway, Valiasr Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1991953381
Phone
+98 21 8820 0118
Fax
Email
Afzalgolnaz95@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All of the information and knowledge achieved from this clinical trial will be published as an article
When the data will become available and for how long
About 6 months after publication of the results.
To whom data/document is available
All of people have access to the information.
Under which criteria data/document could be used
In order to use the same drug for the specific indication in the clinical wards or to use the data for designing another relevant study
From where data/document is obtainable
The information are accessible via e-mail address and phone number:
golnaz afzal, afzalgolnaz95@gmail.com
What processes are involved for a request to access data/document
After the end of trial, the information will be sent for a journal as a manuscript. the manuscript will be reviewed and after that, it will be published as a paper if the journal accepts the manuscript.