The effect of preoperative 1, 25 (OH)2 vitamin D administration on postoperative serum levels of Interleukin 1, Interleukin 6 and Tumor Necrosis Factor-alpha in patients undergoing elective CABG
the aim of study: to determine the effect of 1,25 Vit D3 administered before operation in elective Coronary Artery Bypass Graft on postoperative serum inflammatory factors
Study design: randomized, double blind, placebo controlled, single centered, stage 3 of clinical trial
Study population: patients candidates for elective Coronary Artery Bypass Graft in entering Shahid Modarres cardiac surgery OR.
Inclusion criteria:
1- age 40-75
2- elective Coronary Artery Bypass Graft surgery with CPB
3- constant surgeon
Exclusion criteria
1- Diabetes mellitus
2- Chronic Renal failure (Cr>2mg/dL) before anesthesia
3- chronic renal failure (impaired Liver Function Test)
4- elevated or decreased level of Vit D3 (out of normal range)
5- off pump Coronary Artery Bypass Graft
6- any complications during surgery
7- Pulmonary artery pressure>35 mmHg
8- Ejection Fraction of left ventricle (preoperative) <30%
9- repeated operation during early postoperative period
Sample size: totally 80 patients (40 in each group)
Intervention: Vit D administration and assessment of its effects on inflammatory response of the body
Time of intervention: 2015 (=1394)
Primary outcome for measurement: the systemic inflammatory response of the body which is assessed based on the serum levels of inflammatory interleukins
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201502022804N7
Registration date:2015-05-17, 1394/02/27
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-05-17, 1394/02/27
Registrant information
Name
Ali Dabbagh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2243 2572
Email address
alidabbagh@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Deputy, Shahid Beheshti University of Medical Sciences, Tehran, Iran
Expected recruitment start date
2015-03-21, 1394/01/01
Expected recruitment end date
2017-03-21, 1396/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of preoperative 1, 25 (OH)2 vitamin D administration on postoperative serum levels of Interleukin 1, Interleukin 6 and Tumor Necrosis Factor-alpha in patients undergoing elective CABG
Public title
The effect of preoperative vitamin D administration on postoperative serum levels of Interleukin 1, Interleukin 6 and Tumor Necrosis Factor-alpha in patients undergoing elective CABG
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age 40-75; elective Coronary Artery Bypass Graft with CardioPulmonary Bypass; constant surgeon
Exclusion criteria:
informed written consent; diabetes mellitus; chronic kidney disease causing serum Cr>2mg/dL; hepatic failure causing liver function test failure; high levels of vitamin D; off pump Coronary Artery Bypass Graft; any unwanted complication in the operation period; re-starting CPB after weaning from bypass; Pulmonary artery pressure >30 before operation; Ejection Fraction<30%; re-operation in the postoperative period
Age
From 40 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee, Shahid Beheshti University of Medical Sciences
Street address
Velenjak
City
Tehran
Postal code
1417613151
Approval date
2014-09-23, 1393/07/01
Ethics committee reference number
4
Health conditions studied
1
Description of health condition studied
coronary artery bypass graft
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease
Primary outcomes
1
Description
serum cytokines after CABG
Timepoint
serum cytokines are measure preoperatively as baseline and the after operation
Method of measurement
serum levels detected by ELISA
Secondary outcomes
1
Description
duration of surgery
Timepoint
duration of anesthesia
Method of measurement
cardiopulmonary bypass time
Intervention groups
1
Description
In the intervention group, the patients receive 3 vitamin D pearls each day (each pearl is 50000 units; so 150000 units of vitamin D in each day); these pearls start 1 week before surgery
The pearls are made by Dana Pharmaceuticals, Tabriz, Iran
Category
Treatment - Drugs
2
Description
The control group receives placebo, 3 times a day before one week starting before operation