Comparition of effect of high dose and low dose atorvastatin treatment on outcome of patients underwent CABG. Randomized, double-blind, non-controlled with placebo, 100 patients undergoing CABG on-pump in Namazi hospital. Inclusion criteria: patients admitted in Nemazee hospital who underwent CABG on CPB; after learning of the investigation and completed an informed consent, were randomized to receive atorvastatin are divided into two groups. Exclusion criteria: unstable angina; myocardial infarction; evidence of recent MI (within 6 months); history of previous cardiac surgery; emergency surgery; congenital heart disease; a history of cardiac arrhythmias (Atrial Fibrilation) preoperatively received antiarrhythmic drugs (except Beta blocker); having Pacemaker; Left Ventricle Edjection Fraction less than 30%; uncontrolled hypertension; persistant atrial or ventricular arrhythmia; pregnant women; a history of diabet under treatment; elevated liver enzymes; renal failure with creatinine greater than 2mg/dl; inflammation or immune activation; muscle disease and alergy to statins.
In cases 80 mg atorvastatin daily for 3 days before surgery and post-operative dose of 20 mg daily receives and controls 20 mg atorvastatin daily continuation
different myocardial ischemia between the 2 groups by marker CK-MB and cardiac arrhythmias, blood glucose and kidney function in a variety of groups. CK-MB and C-reactive protein bifor induction,24 and 48 h after operation and blood suger before induction,in and after on-pump and each 6 h up to 48h and then daily in course of admission.Renal function tests befor surgery, day of 1 to 3 after operation and hematocrit befor,under and after on-pump and 3days after operation and LFT befor induction and second day after operation. 1month after surgery patients would be followed for cardiac function and myocardial infarction and need for revascularisation.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012072310311N2
Registration date:2013-09-09, 1392/06/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-09-09, 1392/06/18
Registrant information
Name
Mohammad Bagher Khosravi
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1233 7636
Email address
khosravimb@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2013-08-23, 1392/06/01
Expected recruitment end date
2013-12-22, 1392/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparition of effect of high dose and low dose atorvastatin treatment on outcome of patients underwent CABG
Public title
Atorvastatin in open heart surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: patients admitted in Nemazee hospital who underwent CABG on CPB; after learning of the investigation and completed an informed consent, were randomized to receive atorvastatin are divided into two groups. Exclusion criteria: unstable angina; myocardial infarction; evidence of recent MI (within 6 months); history of previous cardiac surgery; emergency surgery; congenital heart disease; a history of cardiac arrhythmias (Atrial Fibrilation) preoperatively received antiarrhythmic drugs (except Beta blocker); having Pacemaker; Left Ventricle Edjection Fraction less than 30%; uncontrolled hypertension; persistant atrial or ventricular arrhythmia; pregnant women; a history of diabet under treatment; elevated liver enzymes; renal failure with creatinine greater than 2mg/dl; inflammation or immune activation; muscle disease and alergy to statins.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
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
Shiraz University of Medical Sciences
Street address
the central building of shiraz University-zand street
City
shiraz
Postal code
71345-1978
Approval date
2013-08-04, 1392/05/13
Ethics committee reference number
CT-P-92-3628
Health conditions studied
1
Description of health condition studied
Coronary artery bypass graft
ICD-10 code
T82-2
ICD-10 code description
Mechanical complication of coronary artery bypass and valve grafts
Delirium, not induced by alcohol and other psychoactive substances
5
Description of health condition studied
Acute myocardial ischemia and infarction
ICD-10 code
I21
ICD-10 code description
Acute myocardial infarction
Primary outcomes
1
Description
CK-MB
Timepoint
Befor induction, 24 and 48 h after surgery
Method of measurement
Labratory kit
2
Description
CRP
Timepoint
Befor induction, 24 and 48 h after surgery
Method of measurement
Laberatory kit
3
Description
Blood suger
Timepoint
Before induction, in pump, after off pump, every 6h upto48 h, then daily
Method of measurement
Glucometr
4
Description
Atrial fibrilation
Timepoint
During operation, in course of ICU admission
Method of measurement
Continioues ECG monitoring
5
Description
MACE(magor adverse cardiac events)
Timepoint
In ICU and up to 1 month after surgery
Method of measurement
Echocardiography
Secondary outcomes
1
Description
Ceratinin
Timepoint
Before surgery, daily up to 3 days
Method of measurement
Laberatory kit
2
Description
Hematocrit
Timepoint
Before surgery,in pump,off-pump,days of 1&2&3
Method of measurement
Laberatoty kit
3
Description
Liver function tests
Timepoint
Befor surgery,second day after operation
Method of measurement
Lab kit
4
Description
Delirium
Timepoint
In course of ICU admission
Method of measurement
Richmond scale daily
Intervention groups
1
Description
Patients in this study werw generally used 10 to 20 mg atorvastatin daily. Patients in this group, recived Atorvastatin 80 mg daily for 3 days before surgery and received postoperative low dose of 20 mg daily during the ICU stay
Category
Treatment - Drugs
2
Description
The control group received 20 mg atorvastatin daily and continues in ICU
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Namazi hospital
Full name of responsible person
Misagh Bastani. resident of anhesthesiology
Street address
Namazi Square, Zand street, Shiraz
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Gholamreza Hatam
Street address
Office of Research - Seventh Floor - Shiraz University of Medical Sciences - Central Building-zand street
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Misagh Bastani
Position
Resident of anesthesiology
Other areas of specialty/work
Street address
Department of Anesthesiology-Operating room. namazi hospital
City
Shiraz
Postal code
7194714487
Phone
+98 71 1647 4270
Fax
Email
bastanim@sums.ac.ir; misaghbastani@ymail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohamad Bagher Khosravi
Position
Associated professor
Other areas of specialty/work
Street address
Hengam Street. Lane 6/2. Last door on the right. Nyaysh Boulevard.Shiraz.
City
Shiraz
Postal code
Phone
+98 71 1654 1174
Fax
Email
khosravimb@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Misagh Bastani
Position
Resident of anesthesiology
Other areas of specialty/work
Street address
Department of Anesthesiology.Namazi hospital.
City
Shiraz
Postal code
7194714487
Phone
+98 71 1627 0576
Fax
Email
bastanim@sums.ac.ir; misaghbastani@ymail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)