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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00460499
Enrollment
250
Registered
2007-04-16
Start date
2004-07-31
Completion date
2015-03-31
Last updated
2015-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glycemic Control

Keywords

Diabetes

Brief 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.

Detailed 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.

Interventions

DRUGA IV Insulin drip

These patients will receive 100units of insulin in 100ml of saline intravenously to keep blood glucose between 120-180mg/dl.

DRUGB Low Dose GIK

These patients will receive D5W+80unitsInsulin+40mEqKCL IV to keep blood glucose between 120-180mg/dl

DRUGC High Dose GIK

This group will receive D20W+160units IV insulin to keep blood sugar between 120-180mg/dl

Sponsors

American Heart Association
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

* Diabetic CABG patients

Exclusion criteria

* Renal and hepatic failure

Design outcomes

Primary

MeasureTime frame
glycemic control, postoperative morbidity, inflammatory markers24 hours following surgery
glycemic control24 hours following surgery

Secondary

MeasureTime frame
free fatty acid levels24 hours following surgery

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026