Improving Outcomes In Diabetic Patients During CABG Surgery By Optimizing Glycemic Control

Glycemic Control Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00460499
• Other study ID #: H-23735
• Status: Completed
• Phase: Phase 1
• First received: April 12, 2007
• Last updated: June 22, 2015
• Start date: July 2004
• Est. completion date: March 2015

Study information

• Verified date: June 2015
• Source: American Heart Association
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This study seeks to determine whether varying the dose of insulin and glucose in diabetic patients during coronary bypass surgery will improve outcomes in these patients.

Description:

Our previous study has shown that maintaining serum glucose between 120-180mg/dl in the perioperative period during CABG surgery in diabetic patients improves outcomes. The purpose of this trial is: (1) to determine whether outcomes can be improved by altering the content of glucose or insulin in these solutions (2)to determine the effect of these solutions and glycemic control on the inflammatory response of arterial and venous conduits used during surgery, (3) to determine whether the beneficial effects of improved glycemic control can be correlated with changes in the inflammatory response.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Diabetic CABG patients

Exclusion Criteria:

• Renal and hepatic failure

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glycemic Control

Intervention

Drug:
• A IV Insulin drip
These patients will receive 100units of insulin in 100ml of saline intravenously to keep blood glucose between 120-180mg/dl.
• B Low Dose GIK
These patients will receive D5W+80unitsInsulin+40mEqKCL IV to keep blood glucose between 120-180mg/dl
• C High Dose GIK
This group will receive D20W+160units IV insulin to keep blood sugar between 120-180mg/dl

Locations

Country	Name	City	State
United States	Boston Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
American Heart Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	glycemic control, postoperative morbidity, inflammatory markers		24 hours following surgery	No
Primary	glycemic control		24 hours following surgery	No
Secondary	free fatty acid levels		24 hours following surgery	No