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Clinical trial Comparing The Impact Of Selenium, Vitamine C And N-Acetylcystein On Prevention Of Acute Kidney Injury Following Off-Pump coronary artery bypass graft(CABG)

Protocol summary

Summary
Purpose: clinical trial comparing the impact of Selenium, Vitamine C And N-Acetylcystein (NAC) on prevention of acute kidney injury following off-pump CABG. This study is perspective, randomize and not blinded. 320 Patients had been studied by random number table in one of 4 groups (each group 80 patients) selenium, vitamin C, NAC and blank group. In first group 500 mg oral selenium (the trade name Selenase made by Biosyn Pharmacy company) was used in 14 hours before surgery, the dose was repeated 2 hours before surgery again. In vitamin C group, 1500 mg of Vitamin C (made by Exir, Tehran drug and Osve pharmacy companys) as 3 effervescent tablets, that 14 hours before surgery, the dose was repeated 2 hours before surgery again. NAC group received 600 ml/gr NAC (made by Exir pharmacy company) effervescent tablets 14 hours before surgery, the dose was repeated 2 hours before surgery again. Patients in the control group received only the routine care standard. In all of the patients, drug administration, as every 12 hours orally or by nasogastric gavage continued until 3 days after surgery, after surgery patients received a total of 8 doses of drugs.The total daily prescribed drugs to patients was 1,000 mcg of selenium, 3 grams in vitamin C group and NAC groups was equal to 1200 mg. Inclusion criteria: patient satisfaction; off-pump coronary artery bypass graft surgery method; there is no known history of renal including structural abnormalities; kidney failure or patients with a single kidney; non-emergency coronary artery bypass graft. Exclusion criteria: patients with chronic obstructive pulmonary disease; usage more than 2 units of blood during surgery; history of taking non-steroidal anti-inflammatory drugs; acute sepsis; patients with severe malnutrition; diabetes. Primary outcome: acute kidney injury in the form of increased serum creatinine or decreased urine output or both will be determined. Secondary outcome: stay in ICU

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015021621098N1
Registration date: 2017-04-13, 1396/01/24
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-04-13, 1396/01/24
Registrant information
Name
Shahram Amini
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3852 5209
Email address
aminish@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research Mashhad University of Medical Sciences
Expected recruitment start date
2014-11-06, 1393/08/15
Expected recruitment end date
2015-03-06, 1393/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial Comparing The Impact Of Selenium, Vitamine C And N-Acetylcystein On Prevention Of Acute Kidney Injury Following Off-Pump coronary artery bypass graft(CABG)
Public title
Effects of selenium, vitamin C and N-acetylcysteine in the prevention of acute kidney injury after cardiac surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: patient satisfaction; off-pump coronary artery bypass graft surgery method; there is no known history of renal including structural abnormalities; kidney failure or patients with a single kidney; non-emergency coronary artery bypass graft Exclusion criteria: patients with chronic obstructive pulmonary disease; usage more than 2 units of blood during surgery; history of taking non-steroidal anti-inflammatory drugs; acute sepsis; patients with severe malnutrition; diabetes.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 320
Randomization (investigator's opinion)
Randomized
Randomization description
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 Mashhad University of Medical Sciences
Street address
Ghoreishi apartment, Daneshgah street, Mashhad
City
Mashhad
Postal code
Approval date
2014-11-01, 1393/08/10
Ethics committee reference number
930080

Health conditions studied

1

Description of health condition studied
Coronary Atrial Bypass Graft Pations
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease

Primary outcomes

1

Description
Acute kidney injury
Timepoint
Before intervention and every one hour after intervention until the end of Hospitalization
Method of measurement
Measurement of serum creatinine and urine output

Secondary outcomes

1

Description
Stay in ICU
Timepoint
Number of days of stay in ICU after surgery
Method of measurement
Day

Intervention groups

1

Description
Intervention group 1 : 500 mg oral selenium (the trade name Selenase made by Biosyn Pharmacy company) was used in 14 hours before surgery, the dose was repeated 2 hours before surgery again
Category
Treatment - Drugs

2

Description
Intervention group 2 : In vitamin C group, 1500 mg of Vitamin C (made by Exir, Tehran drug and Osve pharmacy companys) as 3 effervescent tablets, that 14 hours before surgery, the dose was repeated 2 hours before surgery again
Category
Treatment - Drugs

3

Description
Intervention group 3 : NAC group received 600 ml/gr NAC (made by Exir pharmacy company) effervescent tablets 14 hours before surgery, the dose was repeated 2 hours before surgery again
Category
Treatment - Drugs

4

Description
Control group: Received only routine care standard
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza hospital intensive care unit
Full name of responsible person
Dr Shahram Amini
Street address
Department of Anesthesia, Imam Reza Hospital, Ibne Sina street, Mashhad
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research, Mashhad University of Medical Science
Full name of responsible person
Hamid Eslami
Street address
Ghoreishi apartment, Daneshgah street, Mashhad
City
Mashhad
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, Mashhad University 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
Mashhad University of Medical Sciences
Full name of responsible person
Shahram Amini
Position
Associate Professor
Other areas of specialty/work
Street address
Department of Anesthesia, Imam Reza Hospital, Ibne Sina street, Mashhad
City
Mashhad
Postal code
Phone
+98 51 3852 5209
Fax
Email
Aminish@mums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Shahram Amini
Position
Associate Professor
Other areas of specialty/work
Street address
Department of Anesthesia, Imam Reza Hospital, Ibne Sina street, Mashhad
City
Mashhad
Postal code
Phone
+98 51 3852 5209
Fax
Email
Amimish@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Shahram Amini
Position
Associate Professor
Other areas of specialty/work
Street address
Department of Anesthesia, Imam Reza Hospital, Ibne Sina street, Mashhad
City
Masshad
Postal code
Phone
+98 51 3852 5209
Fax
Email
aminish@mums.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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