ICTRP Search Portal

Main

Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	IRCT
Last refreshed on:	22 February 2018
Main ID:	IRCT2017080619470N61
Date of registration:	2017-09-07
Prospective Registration:	No
Primary sponsor:	Vice Chancellor for Research, Shiraz University of Medical Sciences
Public title:	Comparison of Preconditioning Effect of High Dose and Low Dose Atorvastatin Treatment in Patients Underwent CABG
Scientific title:	Comparison of Preconditioning Effect of High Dose and Low Dose Atorvastatin Treatment in Patients Underwent CABG
Date of first enrolment:	2013-04-21
Target sample size:	100
Recruitment status:	Complete
URL:	http://en.irct.ir/trial/17434
Study type:	interventional
Study design:	Randomization: Not randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Other design features: Randomization with Random Number Table.
Phase:	4

Countries of recruitment
Iran (Islamic Republic of)

Contacts

Name:	Misagh Bastani
Address:	Anesthesiology Department, Faghihi Hospital, Zand Street Shiraz Iran (Islamic Republic of)
Telephone:	+98 71 3647 4270
Email:	bastanim@sums.ac.ir
Affiliation:	Shiraz University of Medical Sciences

Name:	Mohammad Bagher Khosravi
Address:	Anesthesiology Department, Faghihi Hospital, Zand Street Shiraz Iran (Islamic Republic of)
Telephone:	+98 71 3647 4270
Email:	khosravimb@sums.ac.ir
Affiliation:	Shiraz Universiy of Medical Sciences

Key inclusion & exclusion criteria

Inclusion criteria: Inclusion criteria:
patients who had been taking (atorvastatin 20 mg daily) at least one year prior to the cardiac surgery.
Exclusion criteria:
unstable angina; evidences of recent MI (within 6 months) ; history of cardiac surgery; congenital heart disease; history of cardiac arrhythmia (arterial fibrillation) before surgery; receiving anti- arrhythmic drugs (except Beta blockers) ; having pacemaker; left ventricle ejection fraction less than 30%, uncontrolled hypertension; arterial or ventricular arrhythmia; pregnancy; patient who are undergoing diabetes treatment; increased level of liver enzymes; renal failure with creatinine more than 2 mg/dl; active inflammation or immune deficiency; positive history of muscle disease or reaction to the stations.
Exclusion criteria:

Age minimum: no limit
Age maximum: no limit
Gender: Both

Health Condition(s) or Problem(s) studied

Coronary Artery Bypass Surgery.
Atherosclerotic heart disease

Atherosclerotic heart disease

Intervention(s)

patients in the control group received 20 mg atorvastatin up to surgery and during the one month follow up period they continued their medication with 20 mg atorvastatin daily.

Intervention 1: Patients in the study group received 80 mg atorvastatin daily, for 3 days before surgery and low dose of 20 mg atorvastatin daily during the ICU stay, after surgery, and after discharge, the treatment continued at home with a single dose of 20 mg atorvastatin daily. Intervention 2: patients in the control group received 20 mg atorvastatin up to surgery and during the one month follow up period they continued their medication with 20 mg atorvastatin daily.

Patients in the study group received 80 mg atorvastatin daily, for 3 days before surgery and low dose of 20 mg atorvastatin daily during the ICU stay, after surgery, and after discharge, the treatment continued at home with a single dose of 20 mg atorvastatin daily.

Treatment - Drugs

Primary Outcome(s)

Mechanical ventilation duration in the ICU. Timepoint: After arrival to the ICU. Method of measurement: Observasion.

The serum level of CPK-MB enzymes, troponin I. Timepoint: before induction of anesthesia and 24 ,48 hours after surgery. Method of measurement: Arterial blood sample.

High-sensitivity C-reactive protein (hs-CRP) levels,. Timepoint: before induction of anesthesia and 24 ,48 hours after surgery. Method of measurement: Arterial blood sample.

Secondary Outcome(s)

Blood glucose. Timepoint: After surgery in the intensive care unit. Method of measurement: blood sample.

Glomerular filtration rate (GFR) and urine output. Timepoint: After surgery in the intensive care unit. Method of measurement: observasion.

Secondary ID(s)

Source(s) of Monetary Support

Vice Chancellor for Research, Shiraz University of Medical Sciences

Secondary Sponsor(s)

Ethics review

Status: Approved
Approval date:
Contact:

Ethics committee of Shiraz University of Medical Sciences

Results

Results available:
Date Posted:
Date Completed:
URL:

Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.