A clinical trial to compare the effectiveness of glargine insulin and regular insulin in hyperglycemic control among type II diabetic patients undergoing on-pump coronary artery bypass graft before, during, and after the operation
Red color represents old content. It may be empty showing addition in the new version.
Green color represents new content. It may be empty showing deletion in the new version.
Inline
Side by side
Added new contents,
deleted old contents,contents that are not changed.
New table contents
New table contents
Old table contents
Old table contents
Unchanged contents
Unchanged contents
Added new contents, contents that are not changed.
Deleted old contents, contents that are not changed.
Old table contents
Old table contents
Unchanged contents
Unchanged contents
New table contents
New table contents
Unchanged contents
Unchanged contents
Protocol summary
The effectiveness of glargine insulin and regular insulin in hyperglycemic control among type II diabetic patients undergoing off-pump coronary artery bypass graft.
The effectiveness of glargine insulin and regular insulin in hyperglycemic control among type II diabetic patients undergoing on-pump coronary artery bypass graft.
The effectiveness of glargine insulin and regular insulin in hyperglycemic control among type II diabetic patients undergoing offon-pump coronary artery bypass graft.
مقایسه اثر انسولين گلارژين با انسولين رگولار بر كنترل هایپرگليسمي در بيماران مبتلا به ديابت نوع دوم تحت پيوند عروق كرونر بدون پمپ قلبي ريوي.
مقایسه اثر انسولين گلارژين با انسولين رگولار بر كنترل هایپرگليسمي در بيماران مبتلا به ديابت نوع دوم تحت پيوند عروق كرونر با پمپ قلبي ريوي.
مقایسه اثر انسولين گلارژين با انسولين رگولار بر كنترل هایپرگليسمي در بيماران مبتلا به ديابت نوع دوم تحت پيوند عروق كرونر بدونبا پمپ قلبي ريوي.
General information
empty
the wrong title
the wrong title
empty
وارد شدن اشتباه عنوان کار
وارد شدن اشتباه عنوان کار
A clinical trial to compare the effectiveness of glargine insulin and regular insulin in hyperglycemic control among type II diabetic patients undergoing off-pump coronary artery bypass graft before, during, and after the operation
A clinical trial to compare the effectiveness of glargine insulin and regular insulin in hyperglycemic control among type II diabetic patients undergoing on-pump coronary artery bypass graft before, during, and after the operation
A clinical trial to compare the effectiveness of glargine insulin and regular insulin in hyperglycemic control among type II diabetic patients undergoing offon-pump coronary artery bypass graft before, during, and after the operation
کارآزمایی بالینی مقایسه اثر انسولين گلارژين با انسولين رگولار بر كنترل هایپرگليسمي در بيماران مبتلا به ديابت نوع دوم تحت پيوند عروق كرونر بدون پمپ قلبي ريوي قبل، حین و پس از عمل
کارآزمایی بالینی مقایسه اثر انسولين گلارژين با انسولين رگولار بر كنترل هایپرگليسمي در بيماران مبتلا به ديابت نوع دوم تحت پيوند عروق كرونر با پمپ قلبي ريوي قبل، حین و پس از عمل
کارآزمایی بالینی مقایسه اثر انسولين گلارژين با انسولين رگولار بر كنترل هایپرگليسمي در بيماران مبتلا به ديابت نوع دوم تحت پيوند عروق كرونر بدونبا پمپ قلبي ريوي قبل، حین و پس از عمل
Type II diabetic patients who are candidates for off-pump coronary artery bypass graft surgery at the Ghaem Hospital, Mashhad, Iran, are chosen. In this single-blind study, sealed opaque envelopes will be used to conceal the sequencing. The person responsible for data collection is blind to group allocation and the type of drugs.
Type II diabetic patients who are candidates for on-pump coronary artery bypass graft surgery at the Ghaem Hospital, Mashhad, Iran, are chosen. In this single-blind study, sealed opaque envelopes will be used to conceal the sequencing. The person responsible for data collection is blind to group allocation and the type of drugs.
Type II diabetic patients who are candidates for offon-pump coronary artery bypass graft surgery at the Ghaem Hospital, Mashhad, Iran, are chosen. In this single-blind study, sealed opaque envelopes will be used to conceal the sequencing. The person responsible for data collection is blind to group allocation and the type of drugs.
بیماران مبتلا به ديابت نوع دوم کاندید عمل جراحی پيوند عروق كرونر بدون پمپ قلبي ريوي در بیمارستان قائم مشهد انتخاب می شوند، مطالعه به صورت یک سو کور شده می باشد که از پاکت های مات در بسته برای پنهان سازی استفاده خواهد شد، که مسئول جمع آوری داده ها از اینکه چه كسي در چه گروهي قرار دارد و از نوع داروی مصرفی آن ها آگاهی ندارند.
بیماران مبتلا به ديابت نوع دوم کاندید عمل جراحی پيوند عروق كرونر با پمپ قلبي ريوي در بیمارستان قائم مشهد انتخاب می شوند، مطالعه به صورت یک سو کور شده می باشد که از پاکت های مات در بسته برای پنهان سازی استفاده خواهد شد، که مسئول جمع آوری داده ها از اینکه چه كسي در چه گروهي قرار دارد و از نوع داروی مصرفی آن ها آگاهی ندارند.
بیماران مبتلا به ديابت نوع دوم کاندید عمل جراحی پيوند عروق كرونر بدونبا پمپ قلبي ريوي در بیمارستان قائم مشهد انتخاب می شوند، مطالعه به صورت یک سو کور شده می باشد که از پاکت های مات در بسته برای پنهان سازی استفاده خواهد شد، که مسئول جمع آوری داده ها از اینکه چه كسي در چه گروهي قرار دارد و از نوع داروی مصرفی آن ها آگاهی ندارند.
Protocol summary
Study aim
The effectiveness of glargine insulin and regular insulin in hyperglycemic control among type II diabetic patients undergoing on-pump coronary artery bypass graft.
Design
Totally, 80 patients were chosen from the Ghaem Hospital. In this single-blind, controlled clinical trial, the patients are assigned into parallel groups using simple and successive sampling methods.
Settings and conduct
The patients at Ghaem Hospital are chosen. In this single-blind study, sealed opaque envelopes will be used to conceal the sequencing. The person responsible for data collection is blind to group allocation and the type of drugs.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age of 35-65 years; sustaining ASA II; blood sugar of 150-350 mg/dl; lack of simultaneous emergency surgery or heart-valve surgery.
Exclusion criteria: Having underlying diseases (e.g., pulmonary, liver, kidney, thyroid, and digestive diseases); having a history of open-heart surgery; fever; trauma; carotid artery involvement; sensitivity to insulin glargine
Intervention groups
The intervention group will receive 0.2 units/kg of glargine insulin 2 hours before the surgery. Based on the Van den Berghe national protocol, the regular insulin injection unit is equivalent to the blood glucose of patients divided by 150. The patients will receive these injections intravenously during and after the surgery. After the surgery, in the ICU, the blood glucose level of the patient will be subtracted by 140; accordingly, each patient will receive 4 units of regular subcutaneous insulin injection for every 40.
The control group will receive 0.2 units/kg dextrose 5% 2 hours before the surgery. Regular insulin injection will be similar to the intervention group.
Main outcome variables
The comparison of blood glucose, long hospital days in ICU, type of antibiotic used, and wound dehiscence in control and intervention groups
General information
Reason for update
the wrong title
Acronym
IRCT registration information
IRCT registration number:IRCT20130428013159N12
Registration date:2020-06-16, 1399/03/27
Registration timing:prospective
Last update:2020-07-11, 1399/04/21
Update count:1
Registration date
2020-06-16, 1399/03/27
Registrant information
Name
Shima Sheybani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3764 7230
Email address
sheybanish@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-22, 1399/06/01
Expected recruitment end date
2021-08-23, 1400/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial to compare the effectiveness of glargine insulin and regular insulin in hyperglycemic control among type II diabetic patients undergoing on-pump coronary artery bypass graft before, during, and after the operation
Public title
Effect of glargine insulin on hyperglycemic control in type II diabetic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 35-65 years
Sustaining ASA II
Blood sugar of 150-350 mg/dl
Lack of a simultaneous emergency surgery or heart valve surgery
Exclusion criteria:
Having underlying diseases (e.g., pulmonary, liver, kidney, thyroid, and digestive diseases)
Having history of open-heart surgery
Fever
Trauma
Carotid artery involvement
Sensitivity to insulin glargine
Age
From 35 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
The subjects will be randomly assigned into two groups of 80 patients with www.sealedenvelope.com website. A noninvolved researcher will determine the random assignment sequencing base on block randomization. This site is designed that random assignment groups with no restriction.
Blinding (investigator's opinion)
Single blinded
Blinding description
Type II diabetic patients who are candidates for on-pump coronary artery bypass graft surgery at the Ghaem Hospital, Mashhad, Iran, are chosen. In this single-blind study, sealed opaque envelopes will be used to conceal the sequencing. The person responsible for data collection is blind to group allocation and the type of drugs.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9195965919
Approval date
2020-02-18, 1398/11/29
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1399.076
Health conditions studied
1
Description of health condition studied
Type II diabetic
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus
2
Description of health condition studied
Cardiovascular disease
ICD-10 code
I25
ICD-10 code description
Chronic ischaemic heart disease
Primary outcomes
1
Description
Blood glucose
Timepoint
Before the surgery, every 2 hours intraoperatively, and every 4-24 hours after the surgery
Method of measurement
Glucose meter
Secondary outcomes
1
Description
Long hospital days in ICU
Timepoint
After intervention
Method of measurement
The questionnaire
2
Description
Type of antibiotic used
Timepoint
After intervention
Method of measurement
The questionnaire
3
Description
Wound dehiscence
Timepoint
After intervention
Method of measurement
The questionnaire
Intervention groups
1
Description
Intervention group: The intervention group will receive 0.2 units/kg glargine insulin 2 hours before the surgery. Based on the Van den Berghe national protocol, regular insulin injection unit is equivalent to the blood glucose of patient divided by 150. The patients will receive these injections intravenously during and after the surgery. After the surgery, in the ICU, the blood glucose level of patient will be subtracted by 140; accordingly, each patient will receive 4 units of regular subcutaneous insulin injection for every 40.
Category
Treatment - Drugs
2
Description
Control group: The control group will receive 0.2 units/kg dextrose 5% 2 hours before the surgery. Based on the Van den Berghe national protocol, regular insulin injection unit is equivalent to the blood glucose of patient divided by 150. The patients will receive these injections intravenously during and after the surgery. After the surgery, in the ICU, the blood glucose level of patient will be subtracted by 140; accordingly, each patient will receive 4 units of regular subcutaneous insulin injection for every 40.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Shima Sheybani
Street address
Ghaem Hospital, Ahmadabad Street, Dr. Ali Shariati Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3840 0000
Email
Sheybanish@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
vcresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
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
Mashhad University of Medical Sciences
Full name of responsible person
Shima Sheybani
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Ghaem Hospital, Ahmadabad Street, Dr. Ali Shariati Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3840 0000
Email
Sheybanish@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Shima Sheybani
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Ghaem Hospital, Ahmadabad Street, Dr. Ali Shariati Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3840 0000
Email
Sheybanish@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Shima Sheybani
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Ghaem Hospital, Ahmadabad Street, Dr. Ali Shariati Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3840 0000
Email
Sheybanish@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The total data to be included are the primary and secondary effects to be shared.
When the data will become available and for how long
6 months after printing results
To whom data/document is available
Our data will only be available to researchers working in science center and university.
Under which criteria data/document could be used
Our data will be available for scholars working in science center and university.
From where data/document is obtainable
Shima Sheybani provides the analysis code to the applicants via email: Sheybanish@mums.ac.ir
What processes are involved for a request to access data/document
Applicants can respond to the email of the respondent and receive a response within a week.