Impact of consistent measurement and management of blood glucose on clinical outcomes in patients with type 2 diabetes undergoing coronary artery bypass surgery
This study aim was to evaluating and measuring impact, management and consistent control of glucose on clinical outcomes of patients with diabetes II who undergoing bypass coronary artery surgery. During a year diabetic patients whom undergoing elective coronary artery bypass surgery in Madani educational heart center in Tabriz, according our inclusion criteria that having satisfied were enrolled in this study. And then randomly were divided to one of the study or control groups. And matched together according to sex, age and NYHA class. The number of sample size based on other studies has been determined 70. Before the surgery all of the patients in both groups were inform about the benefits of this research and then if they signed the consent form will continue in the study. Patients were assured that any time they can come out of research.The intervention consisted of an insulin protocol; for the control group hospital routine insulin protocol were performed and for the case group insulin protocol were done.Inclusion criteria were; Patients who underwent elective coronary artery bypass surgery and the first time (with on pump or off pump) , who the day before surgery were be hospitalized; Patients who have type 2 diabetes diagnosed during hospitalization or admission to the hospital by blood sugar test, blood sugar after a meal and a diagnosis of type 2 diabetes after glucose tolerance ; patients who did not have other heart disease exception of coronary artery disease; patients with a creatinine level less than 2, patients who did not have kidney disease; not having another heart attack or another heart surgery at same time; no previous heart surgery; positive history of past severe disease; on-emergency surgery; non-cytotoxic drugs and radiation use.Exiclusion criteria were; the operation of the on pump switch to off pump; addition of other surgery such as surgery aneurysmectomy LV; performed endarterctomy on the involved vessels; unwillingness to continuing research, patient died during the study.The number of sample size based on other studies has been determined 70. Before the surgery all of the patients in both groups were inform about the benefits of this research and then if they signed the consent form will continue in the study. Patients were assured that any time they can come out of research. Data collection tools were questioner and new insulin revised protocol for intravenous infusion of insulin and subcutaneous injection of insulin
before , during and after surgery. The aim of this study is to control patients blood glucose levels.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015050311712N1
Registration date:2015-10-30, 1394/08/08
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-10-30, 1394/08/08
Registrant information
Name
Naiyereh Pishnamaz Ahari
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1658 9680
Email address
pishnamazn@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences and Shahid Madani Cardiovascular Research Center of Tabriz
Expected recruitment start date
2013-08-22, 1392/05/31
Expected recruitment end date
2014-01-20, 1392/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Impact of consistent measurement and management of blood glucose on clinical outcomes in patients with type 2 diabetes undergoing coronary artery bypass surgery
Public title
Integrated measuring blood glucose in diabetic patients undergoing open heart surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria were; Patients who underwent elective coronary artery bypass surgery and the first time (with on pump or off pump) , who the day before surgery were be hospitalized; Patients who have type 2 diabetes diagnosed during hospitalization or admission to the hospital by blood sugar test, blood sugar after a meal and a diagnosis of type 2 diabetes after glucose tolerance ; patients who did not have other heart disease exception of coronary artery disease; patients with a creatinine level less than 2, patients who did not have kidney disease; not having another heart attack or another heart surgery at same time; no previous heart surgery; positive history of past severe disease; on-emergency surgery; non-cytotoxic drugs and radiation use.Exclusion criteria were; the operation of the on pump switch to off pump; addition of other surgery such as surgery aneurysmectomy LV; performed endarterctomy on the involved vessels; unwillingness to continuing research, patient died during the study.The number of sample size based on other studies has been determined 50. Before the surgery all of the patients in both groups were inform about the benefits of this research and then if they signed the consent form will continue in the study. Patients were assured that any time they can come out of research.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences- Enqelab Street- Tehran
City
Tehran
Postal code
*
Approval date
2010-07-20, 1389/04/29
Ethics committee reference number
766/130/د/92
Health conditions studied
1
Description of health condition studied
Diabetes Mellitus
ICD-10 code
E10,E11,E1
ICD-10 code description
Diabetes Mellitus
2
Description of health condition studied
Other specified complications of cardiac and vascular prosthetic devices, implants and grafts
ICD-10 code
I25.1,T82.
ICD-10 code description
T82.8 Other specified complications of cardiac and vascular prosthetic devices, implants and grafts, I25.1 coronary (artery) desease
Primary outcomes
1
Description
Blood Glucos
Timepoint
Three time every six hour before surgery and every one hour due to surgery and after surgery in ICU and every six hour after surgery in ward till discharge
Method of measurement
The level of serum
Secondary outcomes
1
Description
Creatinin
Timepoint
One time befor surgery and three time after surgery
Method of measurement
The level of serum
2
Description
Hospitalization days
Timepoint
Until discharge from the hospital
Method of measurement
Observations and patient file
3
Description
Health costs
Timepoint
At the end of the study
Method of measurement
Health costs form
4
Description
Surgical site infection
Timepoint
Beginning of study on the first, second, third, fourth and fifth after operation
Method of measurement
According fever and purulent discharge from the surgical site
Intervention groups
1
Description
Control group: this group will be undergone insulin protocol common at hospital since entering into the unit until releasing time by regular insulin subcutaneous injection in surgery unit and intensive care unit every 6 hour and venous continuous infusion in intensive care unit and secondary variables will be studied.
Category
Treatment - Drugs
2
Description
Test group: this group will be undergone a revised new protocol of insulin since entering into the unit until releasing time by regular subcutaneous insulin injection in surgery unit and intensive care unit every 6 hour and venous continuous infusion in intensive care unit and secondary variables will be studied.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Madani Hospital
Full name of responsible person
Naiyereh Pishnamaz Ahari
Street address
Shahid Madani Hospital, University Street
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Naiyereh Pishnamaz Ahari
Street address
Nosrat St., Tohid Sq.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
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
2
Sponsor
Name of organization / entity
Shahid Madani Cardiovascular Research Center
Full name of responsible person
Naiyereh Pishnamaz Ahari
Street address
third floor, Heart Clinic Building, in front of the Shahid Madani Hospital, University Avenue
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Madani Cardiovascular Research Center
Proportion provided by this source
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
Tehran University of Medical Sciences
Full name of responsible person
Zahra Rahnavard
Position
PHD
Other areas of specialty/work
Street address
School Of Nursing And Midwifery Of Tehran, Dr. Mir khani St., Tohid Sq.
City
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Fax
Email
z.rahnavard@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Naiyereh Pishnamaz Ahari
Position
Master Degree Student
Other areas of specialty/work
Street address
School Of Nursing And Midwifery Of Tehran, Dr. Mir khani St., Tohid Sq.
City
Tehran
Postal code
Phone
+98 66927171
Fax
Email
yeganeh33@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Science
Full name of responsible person
Alireza Yaghoubi
Position
Professor of Heart Surgery
Other areas of specialty/work
Street address
Shahid Rajaei Heart Hospital
City
Tehran
Postal code
Phone
Fax
Email
alireza.yaghoubi@yahoo.com
Web page address
WWW.RHC.AC.IR
Sharing plan
Deidentified Individual Participant Data Set (IPD)