The aim of this study was to investigate the relationship between micronutrients and the outcomes of patients with open heart surgery. A randomized, double-blind, single center, placebo-controlled study was performed on CABG patients. A total of 200 samples were randomly divided into two subgroups of ADAMEL and normal saline. The initial outcome was a 30-day mortality
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015110924975N1
Registration date:2017-09-26, 1396/07/04
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-09-26, 1396/07/04
Registrant information
Name
Gohar Eslami
Name of organization / entity
Mazandaran University of Medical Scienses
Country
Iran (Islamic Republic of)
Phone
+98 11 3354 3695
Email address
g.eslami@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mazandaran university of medical science
Expected recruitment start date
2015-03-20, 1393/12/29
Expected recruitment end date
2016-03-19, 1394/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The impact of administration of micronutrients on clinical outcomes in ICU patients following open heart surgery
Public title
The impact of administration of micronutrients on clinical outcomes in ICU patients following open heart surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Exclusion criteria: Patients with heart failure with discharge fraction (EF) less than 40%؛ The history of COPD, hyperthyroidism؛ Occurrence of MI after surgery؛ Patient's need for Pace؛ The need for re-surgery for any reason؛ Previous history of heart surgery و Inclusion criteria:The patient's willingness to participate in the study after providing information about the study and obtaining informed consent؛ Candidate for Non-Emergency CABG Surgery؛ Use of a pulmonary pump during operation؛ There is no history of tachyarrhythmias treated before surgery (including AF)؛ Having hemodynamic stability (50 MAP & heart rate between 50 - 110)؛ Age between 20 and 75 years
Age
From 20 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
200
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 of Mazandaran University of Medical Sciences
Street address
Research Deputy of MazandaranUniversity of Medical Sciencesm Moalem Square,
City
Sari
Postal code
Approval date
2016-09-22, 1395/07/01
Ethics committee reference number
IR.MAZUMS.REC.95.2468
Health conditions studied
1
Description of health condition studied
heart surgery
ICD-10 code
I79.8
ICD-10 code description
Other disorders of arteries, arterioles and capillaries in diseases classified elsewhere
Primary outcomes
1
Description
Mortality 30 Days After Sergery
Timepoint
After Sergery to 1 Month Later
Method of measurement
File
Secondary outcomes
1
Description
Arrhythmias after surgery
Timepoint
AFTER SERGERY
Method of measurement
FILE
2
Description
Charge of Hospital
Timepoint
After Sergery
Method of measurement
File
3
Description
lenght of Hospital
Timepoint
After Sergery
Method of measurement
FILE
4
Description
Lenght of Mechanical Ventilation
Timepoint
After Sergery
Method of measurement
File
5
Description
Incidence of Renal Failure
Timepoint
After Sergery
Method of measurement
File
6
Description
Lenght of ICU
Timepoint
After Sergery
Method of measurement
File
7
Description
Charge of ICU
Timepoint
After Sergery
Method of measurement
File
Intervention groups
1
Description
Adamel, 10 CC Infusion, daily
Category
Treatment - Drugs
2
Description
Normal Saline, 10 CC.Infusion, Daily
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemeh Zahra hospital of Mazandaran University of Medical Sciences
Full name of responsible person
Areia Soleimani
Street address
Sari
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Majid Saeedi
Street address
Vice Chancellor for Research, Moalem Square
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Asistance of professor of clinical pharmacy
Full name of responsible person
Gohar Eslami
Position
Faculty of Pharmacy, Mazandaran University of Medical Sciences
Other areas of specialty/work
Street address
Faculty of Pharmacy, Payambar Azam Complex, 18 Km Farah Abad Blvd, Khazar Square
City
Sari
Postal code
Phone
+98 11 3354 3082
Fax
Email
g.eslami@mazums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Gohar Eslami
Position
Asistance of Professor
Other areas of specialty/work
Street address
Sari
City
Sari
Postal code
Phone
00
Fax
Email
g.eslami@mazums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Pharmacy, Mazandaran University of Medical Sciences
Full name of responsible person
Gohar Eslami
Position
Asistance of Professor Clinical Pharmacy
Other areas of specialty/work
Street address
Sari
City
Sari
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)