In this prospective study after signing inform consent,150 patients randomly assigned to either control group(75 patients) or intervention group(75 [patients). The inclusion criterion: patients who candidates to Coronary Artery Bypass Graft (CABG) without valve surgery.
Exclusion criteria: age>18 yr; accompanied other surgeries; ejection fraction>40%; history of recent alcohol use or soluble vitamins; emergency surgery; off-pump CABG and sensitivity to thiamine. In intervention group after surgery and when patients arrive ICU, will receive a bolus intravenous dose of 200 mg thiamine followed by 50 mg/hr infusion for 24 hours. The control group receive normal saline as a placebo with same characteristic of thiamine solution regarding volume and other features. Before administration the thiamine the sample of blood drives for base thiamine blood level. After 24 hour again thiamine blood level will be measured. Blood lactate will be measured at times of 0,6,12 and 24 hours. TNF α will be measured giving thiamine before and 24 hr later. Intubation time, length of stay in ICU and hospital and one month mortality rate would be the secondary outcomes.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201702152622N3
Registration date:2017-05-20, 1396/02/30
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-05-20, 1396/02/30
Registrant information
Name
Khosro Barkhordari
Name of organization / entity
Tehran Heart Center
Country
Iran (Islamic Republic of)
Phone
+98 21 8802 9600
Email address
kbarkhordari@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2017-04-07, 1396/01/18
Expected recruitment end date
2018-02-19, 1396/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of thiamine effect on early outcome in patients with low systolic ejection fraction after cardiac surgery
Public title
Evaluation of thiamine effect on heart failure
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria :CABG candidates; ejection fraction>40%; age >18 years old.
Exclusion criteria: emergency operation; accompanying surgery; history of recent alcohol abuse; EF>40%; recent consumption of group B vitamins and Cefteriaxone; off pump CABG; sensitivity to group B vitamins .
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
150
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
Ethic Comittee of Theran Faculty of Medicine
Street address
Tehran University of Medical Sciences, Keshavarz boulevard
City
Tehran
Postal code
Approval date
2017-02-06, 1395/11/18
Ethics committee reference number
IR.TUMS.MEDICINE.ERC 1395.1656
Health conditions studied
1
Description of health condition studied
Cardiac failure
ICD-10 code
I50
ICD-10 code description
Heart failure
Primary outcomes
1
Description
Blood lactate level
Timepoint
0, 6, 18, and 24 hours after intervention
Method of measurement
Bloos sample lab test
Secondary outcomes
1
Description
intubation time
Timepoint
During hospitalization
Method of measurement
clinical assessment
2
Description
Duration of hospitalization
Timepoint
During hospitalization
Method of measurement
Clinical Assessment
3
Description
length of stay in ICU
Timepoint
During hospitalization
Method of measurement
Clinical Assessment
4
Description
One-month mortality
Timepoint
1 mo after ICU admision
Method of measurement
Clinical Assessment
Intervention groups
1
Description
The intervention group receives Thiamine as 200 mg bolus dose during 30 minutes followed by 50 mg/hr to 24 hours.
Category
Treatment - Drugs
2
Description
The control group receives normal saline as the placebo similar to Thiamine administration in intervention group.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran Heart Center hospital
Full name of responsible person
Khosro Barkhordari
Street address
Tehran Heart Center hospital, North Kargar St.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Miss Hajar Moamaei
Street address
Tehran University of Medical Sciences, Keshavarz blvd.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran Heart Center hospital
Full name of responsible person
Dr. Khosro Barkhordari
Position
Asssistant prof
Other areas of specialty/work
Street address
Tehran Heart Center hospital, North Kargar St.
City
Tehran
Postal code
Phone
+98 21 8802 9600
Fax
Email
kh.barkhordari@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran Heart Center hospital
Full name of responsible person
Khosro Barkhordari
Position
Assistant prof
Other areas of specialty/work
Street address
Tehran Heart Center hospital, North Kargar St.
City
Tehran
Postal code
Phone
+98 912 390 3641
Fax
Email
kh.barkhordari@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran Heart Center hospital
Full name of responsible person
Dr. Khosro Barkhordari
Position
Assiistant prof
Other areas of specialty/work
Street address
Tehran Heart Center hospital, North Kargar St.
City
Tehran
Postal code
Phone
+98 21 8802 9600
Fax
Email
kh.barkhordari@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)