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Clinical Trials/NCT00460499
NCT00460499
Completed
Phase 1

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

American Heart Association1 site in 1 country250 target enrollmentJuly 2004

Overview

Phase
Phase 1
Intervention
B Low Dose GIK
Conditions
Glycemic Control
Sponsor
American Heart Association
Enrollment
250
Locations
1
Primary Endpoint
glycemic control
Status
Completed
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2004
End Date
March 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Harold L. Lazar MD

Professor of Cardiothoracic Surgery

American Heart Association

Eligibility Criteria

Inclusion Criteria

  • Diabetic CABG patients

Exclusion Criteria

  • Renal and hepatic failure

Arms & Interventions

B Low dose GIK

This group will have low doses of glucose and insulin

Intervention: B Low Dose GIK

C High Dose GIK

This group will have high doses of insulin and glucose

Intervention: C High Dose GIK

A Insulin

This group will receive only an intravenous insulin infusion

Intervention: A IV Insulin drip

Outcomes

Primary Outcomes

glycemic control

Time Frame: 24 hours following surgery

glycemic control, postoperative morbidity, inflammatory markers

Time Frame: 24 hours following surgery

Secondary Outcomes

  • free fatty acid levels(24 hours following surgery)

Study Sites (1)

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