Objectives: To investigate the effect of GIK on tissues perfusion such as cardiac ischemia during coronary artery bypass surgery. The markers such as serum lactate as an indicator are used for the assessment of myocardial perfusion CVO2 after coronary artery bypass surgery. Design of the study: randomized double blind clinical trial. Sample Size: 74 patients found eligible based on the inclusion criteria. Patients were randomly divided into two groups of intervention group and placebo group. Inclusion criteria: age 80-30 years, the first heart surgery, coronary artery bypass graft surgery, the patient informed consent for inclusion EF, less than 40%. Exclusion criteria: Pregnancy; lack of informed consent; patients undergoing dialysis; 200 mmol / L ↑ Cr; acute coronary syndrome; 5- 350 < FBS; In the circumstances that infusion of GIK will be stopped: 5.5 mmol / L <K increased cardiac markers such as troponin and CPK Interventions: Patients in the intervention group one received infusion of GIK 40 m eq kcl plus 40 unit Reg ins plus 500 cc DW 10% after induction of anesthesia then serum lactate will be measured after induction of anesthesia and insertion of central venous catheter, CVO2 sat in 0 - 24 and 48 hours will be measured.
While, in the group two patients were received infusion of normal saline after induction of anesthesia. Serum lactate was measured and after central venous catheter insertion CVO2 sat was measured at 0-24 and 48 hours.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015012019470N13
Registration date:2016-04-10, 1395/01/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-04-10, 1395/01/22
Registrant information
Name
Farzaneh Masihi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4270
Email address
masihif@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Shiraz University of Medical Sciences
Expected recruitment start date
2016-02-20, 1394/12/01
Expected recruitment end date
2016-05-21, 1395/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of infusion of GIK (glucose-Insulin-potassium ) solution on serum lactate and central VO2 during CABG surgeries
Public title
Evaluation of the effect of infusion of GIK (glucose-Insulin-potassium ) solution on serum lactate and central VO2 during CABG surgeries
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age 80-30 years, the first heart surgery, coronary artery bypass graft surgery, the patient informed consent for inclusion; EF less than 40%
Exclusion criteria: Pregnancy; lack of informed consent; patients undergoing dialysis; 200 mmol / L ↑ Cr; acute coronary syndrome; 5- 350 < FBS; In the circumstances that infusion of GIK will be stopped: 5.5 mmol / L <K increased cardiac markers such as troponin and CPK
Age
From 30 years old to 80 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
74
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 Committee of Shiraz University Of Medical Sciences
Street address
Central Building of Shiraz University of Medical Sciences, Zand Street
City
Shiraz
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
CP-P-9375-7915
Health conditions studied
1
Description of health condition studied
Cardiac Surgeries
ICD-10 code
197.1
ICD-10 code description
Cardiac insufficiency Heart failure following cardiac surgery or due to presence of cardiac prosthesis
Primary outcomes
1
Description
To determine the effect of GIK on serum lactate
Timepoint
At 0-24 and 48 hour after surgery
Method of measurement
Blood sample
Secondary outcomes
1
Description
To determine the effect of GIK on incresing CVO2
Timepoint
At 0-24 and 48 hour after surgery
Method of measurement
ABG of blood sample from central vein
Intervention groups
1
Description
Intervention group: After induction of anesthesia, patents received GIK (40 m eq kcl plus 40 unit Reg ins plus 500 cc DW 10% ) with continuous infusion and the rate of 1 cc / kg / h to 24 h
Category
Treatment - Drugs
2
Description
Control group:patients in the control group received infusion of normal saline after induction of anesthesia.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Namazee Hospital
Full name of responsible person
Ensieh Shahriari
Street address
Anesthesiology Office, Namazi Hospital, Zand Street
City
Shiraz
2
Recruitment center
Name of recruitment center
Shahid Faghihi Hospital
Full name of responsible person
Ensieh Shahriari
Street address
Zand Street, Faghihi Hospital
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Shiraz University of Medical Sciences
Full name of responsible person
Dr Seed Basir Hashemi
Street address
Vice Chancellor for Research, Shiraz University of Medical Sciences, 7th floor, Central Building of Shiraz University of Medical Sciences, 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
Vice Chancellor for Research, 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
Ensieh Shahriari
Position
Physician, Anesthesiology Resident
Other areas of specialty/work
Street address
Anesthesiology Department, Shahid Faghihi Hospital, Zand street
City
Shiraz
Postal code
Phone
+98 71 3647 4270
Fax
Email
en_saeidi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University Of Medical Sciences
Full name of responsible person
Shahrbano Shahbazi
Position
Cardio-Anesthesiologist
Other areas of specialty/work
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Postal code
Phone
+98 71 3647 4270
Fax
Email
sh_shahbazi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Farzaneh Masihi
Position
English Consultant,Anesthesiology Research Center Staff
Other areas of specialty/work
Street address
Anesthesiology Office, Namazi Hospital
City
Shiraz
Postal code
Phone
+98 71 3647 4270
Fax
Email
masihifarzaneh@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)