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
-
-
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
-
-
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
-
Ethics committees
1
-
Ethics committee
-
-
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
1
-
Sponsor
-
-
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
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.
-
Comments
-