Effect of infusion of GIK(Glucose-Insulin-Potassium) solution on clinical outcomes after heart surgery under cardiopulmonary bypass in children in Shahid Chamran Hospital in 2016
Determining the effect of administration of glucose, insulin, potassium (GIK) on clinical outcomes after pediatric cardiopulmonary bypass surgery in comparison with the control group
Design
This is a one-stop clinical trial with parallel groups that randomly assign individuals to each group.
Settings and conduct
This study was conducted at Shahid Chamran Hospital in Isfahan. Blinding in this study was one-sided blind, in which the only anesthesiologist was aware of the type of treatment being prescribed.
Participants/Inclusion and exclusion criteria
Pediatric Heart Disease Candidate for Heart Surgery under the Pulmonary Pump
Age less than 12 years
Parental consent to participate in the study
And exit criteria
Disagreement with parents
Intervention groups
In the first group, the intervention group, glucose-insulin-potassium (GIK) solution was infused in ICU after induction of anesthesia up to 12 hours after surgery.
The second group, the control group, was equivalent to the amount of solution received in the normal saline infusion group.
Main outcome variables
Arrhythmia; need for shock and injection of inotrop; duration of mechanical ventilation; duration of hospitalization in the ICU and section; incidence of renal failure and the need for dialysis; duration of sternum openness
General information
Reason for update
Acronym
GIK solution
IRCT registration information
IRCT registration number:IRCT20190109042306N1
Registration date:2019-02-16, 1397/11/27
Registration timing:retrospective
Last update:2019-02-16, 1397/11/27
Update count:0
Registration date
2019-02-16, 1397/11/27
Registrant information
Name
Azade tavangar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7735 7593
Email address
abbaskhodaeimehr@hlth.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2015-03-21, 1394/01/01
Expected recruitment end date
2016-03-19, 1394/12/29
Actual recruitment start date
2015-03-21, 1394/01/01
Actual recruitment end date
2016-03-19, 1394/12/29
Trial completion date
2016-03-19, 1394/12/29
Scientific title
Effect of infusion of GIK(Glucose-Insulin-Potassium) solution on clinical outcomes after heart surgery under cardiopulmonary bypass in children in Shahid Chamran Hospital in 2016
Public title
Effect of administration of GIK (Glucose-Insulin-Potassium) Solution on clinical outcomes after heart surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Pediatric Heart Disease Candidate for Heart Surgery under the Pulmonary Pump
Age less than 12 years
Parental consent to participate in the study
Exclusion criteria:
Disagreement with parents
Age
To 12 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
70
Actual sample size reached:
70
Randomization (investigator's opinion)
Randomized
Randomization description
All eligible patients were randomly assigned to the intervention group and the control group based on the last digit of the hospital identification number. randomization was performed as one-side-blind in such a way that only an anesthetist was aware of the type of intervention given to each patient.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, with the exception of the anesthetist, all patients were unaware of the type of treatment received
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Hezar Jarib Ave, Darvaze Shiraz
City
Isfahan
Province
Isfehan
Postal code
7346181746
Approval date
2014-04-25, 1393/02/05
Ethics committee reference number
395674
Health conditions studied
1
Description of health condition studied
Children with heart disease
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Clinical outcomes after pediatric cardiac surgery under a cardiac pulmonary pump
Timepoint
Measurements were performed before the cardiovascular pump was connected to the end of the surgery every hour and at the ICU every 6 hours
Method of measurement
Blood glucose and blood pressure tests were performed using the appropriate test
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group (GIK group): In this group, glucose-insulin-potassium (GIK) solution was infused in ICU after induction of anesthesia up to 12 hours after surgery. The dosages were: insulin 0.05 units per kg / h, glucose 0.5 g / kg / h, and potassium 0.5 mg / kg / h.
Category
Treatment - Drugs
2
Description
Control group: In this group, normal saline solution was injected in the same volume as the intervention group (20 cc)
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Chamran Hospital in Isfahan
Full name of responsible person
Azade Tavangar
Street address
Hezar Jarib Ave, Darvaze Shemiran
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 21 7735 7593
Email
abbaskhd666@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
shaghayegh hagh jooy javanmard
Street address
Hezar Jarib Ave,Darvaze Shiraz
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 21 7735 7593
Email
abbaskhd666@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
50
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Azade Tavangar
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Hezar Jarib Ave,Darvaze Shiraz
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 21 7735 7593
Email
abbaskhd666@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Azade Tavangar
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Hezar Jarib Ave,Darvaze Shu=iraz
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 21 7735 7593
Email
abbaskhd666@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Azade Tavangar
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Hezar Jarib Ave
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 21 7735 7593
Email
abbaskhd666@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available