The purpose of the study: Compared the outcome of patients undergoing open cardiac surgery to two methods of glycemic control: 1- Tight Control2-Conventional. Inclusion criteria: Diabetes; Age:18-70; ASA 2-3; All of on pomp cardiac surgery
Exclusion criteria: Off pomp cardiac surgery; Ketoasidosis or Hyperosmolar coma; Redosurgery; History of TIA or CVA. In this open label randomized clinical trial 74 diabetic patients undergoing open heart surgery will enrolled in the two groups. if the blood sugar is above 100 mg /dL) in group 1 insulin infusion rate is adjusted according to blood glucose between 100-120mg/dl. Patients in group 2 were BS greater than or equal to 200 mg/dl can be treated with insulin. Mortality, Sternal wound infection, Duration of mechanical ventilation, Cardiac arrhythmia, Cerebrovascular attack and Acute renal failure are primary outcomes. 30 days after discharge, patients were seen by the surgeon and the occurrence of adverse events are recorded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013041713052N1
Registration date:2013-07-09, 1392/04/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-07-09, 1392/04/18
Registrant information
Name
Fatemeh Javaherforoosh Zadeh
Name of organization / entity
Jondishapoor University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1391 9315
Email address
javaherforoosh-f@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Resources Research Council of Shiraz University of Medical Sciences
Expected recruitment start date
2013-03-19, 1391/12/29
Expected recruitment end date
2014-03-21, 1393/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of patients᾿ outcome in open cardiac surgery with two methods of blood glucose control:1-Thigt 2-Conventional
Public title
Impact on outcome of glycemic control in diabetic patients undergoing open heart surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Diabetes; Age:18-70; ASA 2-3; All of on pomp cardiac surgery
Exclusion criteria: Off pomp cardiac surgery; Ketoasidosis or Hyperosmolar coma; Redosurgery; History of TIA or CVA
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
74
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Council of Shiraz University of Medical Sciences
Street address
6/2, Golab Lane ,Hengam St Niayesh blv
City
Shiraz
Postal code
Approval date
2013-07-24, 1392/05/02
Ethics committee reference number
91-01-60-5268
Health conditions studied
1
Description of health condition studied
daiabetes
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus
Primary outcomes
1
Description
dedth
Timepoint
in the ICU and after 30 days
Method of measurement
Observation of ECGflat
2
Description
wound infection
Timepoint
in the ICU and after 30 days
Method of measurement
Observation
3
Description
mecanical ventilation time
Timepoint
in the ICU
Method of measurement
hours after arival in the ICU
4
Description
cardiac aritmia
Timepoint
in the ICU and after 30 days
Method of measurement
with ECG
5
Description
strock
Timepoint
in the ICU and after 30 days
Method of measurement
with symptoms
6
Description
ARF
Timepoint
in the ICU and after 30 days
Method of measurement
WITH BUN,cr
Secondary outcomes
1
Description
ICU staying
Timepoint
from arival to discharg from ICU
Method of measurement
DAY
Intervention groups
1
Description
In the intervention group, glycemic control using insulin to target blood glucose100- 120 done
Category
Treatment - Drugs
2
Description
In the control group, the treatment of blood glucose greater than 200 target value 180-200mg/dl.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Faghihy Hospital
Full name of responsible person
Dr Fatemeh Javaherforoosh Zadeh
Street address
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Council of Shiraz University of Medical Sciences
Full name of responsible person
Dr G.R.Hatam
Street address
Shahid Faghihi Hospital
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Council of Shiraz 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
Joundishapoor University Of Medical Sciences
Full name of responsible person
Dr Fatemeh Javaherforoosh Zadeh
Position
Anestheiologist
Other areas of specialty/work
Street address
Razy Hospital
City
Ahvaz
Postal code
Phone
+61 13919315
Fax
Email
javaherforoosh-f@ajums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Jondishapoor University Of Medical Sciences
Full name of responsible person
Dr Fatemeh Javaherforoosh Zadeh
Position
Anesthesiologist
Other areas of specialty/work
Street address
Razy hospital
City
Ahvaz
Postal code
Phone
+61 13919315
Fax
Email
javaherforoosh-f@ajums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Jondishapoor University Of Medical Sciences
Full name of responsible person
Dr Fatemeh Javaherforoosh Zadeh
Position
Anesthesiologist
Other areas of specialty/work
Street address
Razy Hospital
City
Ahvaz
Postal code
Phone
+61 13919315
Fax
Email
javaherforoosh-f@ajums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)