Objectives: In this study the effect of insulin as an effective treatment in reducing critical illness of polyneuropathy and myopathy during one year and a half in 30 cases of patients who undergo mechanical ventilation in pediatric intensive care unit of Tabriz Children's Hospital will be studied.
Design: The study is clinical trial and 30 mentioned patients are divided into two groups; In first group with 15 patient insulin is used in order to keep blood sugar in range of 140-180 milligram per decilitre.In second group with 15 patient,distilled water as placebo will be used.
Setting and conduct: Appropriate protocol will be continuous injection of insulin as drip.Injection of distilled water will be also continuous and as drip like insulin.Note that the injection will be as same as first group and will be done by a person with no information about polymyopathy and neuropathy.
Participants including major eligibility criteria: In this study the effect of insulin as an effective treatment in reducing critical illness of polyneuropathy and myopathy during one year and a half in 30 cases of patients who undergo mechanical ventilation in pediatric intensive care unit of Tabriz Children's Hospital will be studied.Confounding variables are important in this study and the following people are excluded from study; spinal cord injuries; patients with Guillain Barre Syndrome; myasthenia gravis; patients with central nervous system problems or neuromuscular disease causing muscle weakness and paralysis
before or during the hospitalization; hypophosphatemia.
Interventions: In first group with 15 patients if blood sugar rises more than 180 milligram per decilitre insulin will be injected 0.5 unit per kilogram with serial control of blood sugar each hour (of course blood sugar will be kept between 140 to 180 milligram per decilitre until patient is connected to mechanical ventilator).In second control group with 15 patients distilled water as placebo will be used.The form of administring will be 0.5 unit per kilogram with serial control of blood sugar each hour like first group.
Main outcome measures variables: Our main outcome measures variable is
blood sugar.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201108117295N1
Registration date:2012-02-16, 1390/11/27
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-02-16, 1390/11/27
Registrant information
Name
Nemat Bilan
Name of organization / entity
Tabriz Univercity of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1526 2280
Email address
bilan@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
The financial resources of the Research will be provided by Institute of Tuberculosis and Lung Disease, TABRIZ University of Medical Sciences
Expected recruitment start date
2010-09-23, 1389/07/01
Expected recruitment end date
2012-03-19, 1390/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The role of insulin therapy in reducing critical illness polyneuropathy and myopathy in pediatric intensive care unit
Public title
The role of insulin therapy in reducing critical illness polyneuropathy and myopathy in pediatric intensive care unit
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria and who are under investigation in this study are the following:
In this study,during one year and a half,30 of patients admitted to the pediatric intensive care unit of Tabriz Children's Hospital and are more than one week under mechanical ventilation and in the course of their hospitalization experience hyperglycemia (more than 180 milligram per decilitre) are divided into two groups; In first group with 15 patient insulin is used in order to keep blood sugar in range of 140-180 milligram per decilitre (until the patient is connected to the ventilator); In second group with 15 patient,distilled water as placebo will be used (Note that injection will be done by a person who has no information about the polyneuropathy and myopathy).
Confounding variables are important in this study and the following people are excluded from study; spinal cord injuries; patients with Guillain Barre Syndrome; myasthenia gravis; patients with central nervous system problems or neuromuscular disease causing muscle weakness and paralysis
before or during the hospitalization; hypophosphatemia.
Appropriate methods to control confounding variables are according to observation,periods of physical examination,laboratory results such as blood and cerebro spinal fluid tests and EMG and NCV. It should be noted that the removal of these patients are so that in each point of the study (before the start of or during the study) if each of 5 problems above found by methods such as Electromygraphy and testing of cerebrospinal fluid or physical examination period,the patient will be excluded.
Age
From 1 year old to 14 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
30
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
The ethics committee of Tabriz University of Medical Sciences, Faculty of Medicine
Street address
Faculty of Medicine, Tabriz University of Medical Sciences, Golgasht Avenue, Tabriz
City
Tabriz
Postal code
5165665931
Approval date
2011-06-06, 1390/03/16
Ethics committee reference number
2109.4.5
Health conditions studied
1
Description of health condition studied
polyneuropathy and myopathy
ICD-10 code
E10,E11.E1
ICD-10 code description
Diabetic polyneuropathy
Primary outcomes
1
Description
blood glucose
Timepoint
Serial monitoring of blood glucose per hour (the aim of maintaining blood glucose range 140-180 milligram per decilitre)
Method of measurement
Glucometry
Secondary outcomes
1
Description
Polyneuropathy and myopathy
Timepoint
After extubation
Method of measurement
Electromyography
Intervention groups
1
Description
In this study,during one year and a half,30 of patients admitted to the pediatric intensive care unit of Tabriz Children's Hospital and are more than one week under mechanical ventilation and in the course of their hospitalization experience hyperglycemia (more than 180 milligram per decilitre) are divided into two groups; In first group with 15 patients,in which the intervention is done, insulin is used in order to keep blood sugar in range of 140-180 milligram per decilitre (until the patient is connected to the ventilator).Appropriate protocol will be continuous injection of 0.5 unit per kilogram insulin as drip with serial control of blood sugar each hour with the goal of keeping blood sugar between
140-180 milligram per decilitre. Note that the injection will be as same as first group and will be done by a person with no information about polymyopathy and neuropathy.
Category
Treatment - Drugs
2
Description
In second group with 15 patients which is called control group,distilled water as placebo will be used.Appropriate protocol in using distilled water,like insulin injection in intervened group,is continuous injection of 0.5 unit per kilogram insulin as drip with serial control of blood sugar each hour.Note that the injection will be done by a person with no information about polyneuropathy and myopathy and the injected substance.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Children's Hospital of Tabriz
Full name of responsible person
Nemat Bilan
Street address
Children's Hospital, Sheshgalan Avenue, Tabriz
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of Medical Sciences
Full name of responsible person
Ali Meshkini
Street address
Tuberculosis Research Centre, Vice chancellor for research, Faculty of Medicine, Tabriz University of Medical Sciences, Golgasht, 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, Tabriz University of Medical Sciences