Objective: Studying the effect of tight control of blood glucose on
complications rate after Pediatric cardiac surgery.
Design: Prospective randomized clinical trial Setting and conduct: Fifty pediatric
patients under 12 years olds candidate for elective cardiac surgery, randomly
will be allocated in two Insulin and placebo groups (N=25).
Inclusion criteria: Patients under 12 Years olds who are candidate for elective
cardiac surgery With cardiopulmonary bypass.
Exclusion criteria: Diabetics; Urgent surgery; Multi-organ failure; Left ventricle
Ejection fraction lower than 40 %; Redo surgery.
Intervention: Starting infusion of Insulin regular 0.1 u/ ml after induction of
anesthesia up to end of Surgery in study group, and infusion of saline normal
in placebo group.
Outcome measures: Postoperative mortality and morbidity.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014052316117N2
Registration date:2014-10-15, 1393/07/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-10-15, 1393/07/23
Registrant information
Name
Bahman Naghipour Basmenj
Name of organization / entity
Tabriz Univesity of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3337 3950
Email address
naghipourb@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2013-12-22, 1392/10/01
Expected recruitment end date
2014-10-22, 1393/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Hyperglycemia Treatment on Complications Rate after Pediatric Cardiac Surgery.
Public title
Effect of Hyperglycemia Treatment on Complications Rate after Pediatric Cardiac Surgery.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria : Childeren with age under 12 years undergoing cardiac surgery with cardiopulmonary bypass ( CPB).
Exclusion criteria :
Diabetics; Urgent surgery; Multi-organ failure; Left ventricle Ejection fraction lower than 40 %; Redo surgery.
Age
From 1 day old to 12 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomization with online software (random.org )
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Scienses
Street address
Golgasht, Daneshgah Street, Tabriz
City
Tabriz
Postal code
Approval date
2013-11-18, 1392/08/27
Ethics committee reference number
92139
Health conditions studied
1
Description of health condition studied
Complications of pediatric heart surgery
ICD-10 code
Y83.9
ICD-10 code description
Surgical procedure, unspecified
Primary outcomes
1
Description
Postoperative complications
Timepoint
Hospital stay and ICU stay time period
Method of measurement
Questionnaire
2
Description
Mortality rate
Timepoint
Hospital stay and ICU stay time period
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group :
Starting infusion of Insulin regular 0.1 u/ ml after induction of anesthesia up to end of
Surgery.
Category
Treatment - Drugs
2
Description
Control group : Infusion of saline normal during surgery.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Madani Hospital
Full name of responsible person
Dr. Bahman Naghipour
Street address
Madani Heart Center, Daneshgah Street, Tabriz.
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research of Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Reza Rashidi
Street address
Tabriz University of Medical Sciences, Daneshgah Street, Tabriz
City
Tabriz
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 of Tabriz 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
Medicine faculty, Tabriz University of Medical Sciences