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

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ClinicalTrials.gov Identifier: NCT00460499
Recruitment Status : Completed
First Posted : April 16, 2007
Last Update Posted : June 23, 2015
Sponsor:
Information provided by (Responsible Party):
Harold L. Lazar MD, American Heart Association

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.

Condition or disease Intervention/treatment Phase
Glycemic Control Drug: A IV Insulin drip Drug: B Low Dose GIK Drug: C High Dose GIK Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : July 2004
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: B Low dose GIK
This group will have low doses of glucose and insulin
Drug: B Low Dose GIK
These patients will receive D5W+80unitsInsulin+40mEqKCL IV to keep blood glucose between 120-180mg/dl

Active Comparator: C High Dose GIK
This group will have high doses of insulin and glucose
Drug: C High Dose GIK
This group will receive D20W+160units IV insulin to keep blood sugar between 120-180mg/dl

Active Comparator: A Insulin
This group will receive only an intravenous insulin infusion
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.




Primary Outcome Measures :
  1. glycemic control, postoperative morbidity, inflammatory markers [ Time Frame: 24 hours following surgery ]
  2. glycemic control [ Time Frame: 24 hours following surgery ]

Secondary Outcome Measures :
  1. free fatty acid levels [ Time Frame: 24 hours following surgery ]


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diabetic CABG patients

Exclusion Criteria:

  • Renal and hepatic failure

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00460499


Locations
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
American Heart Association
Investigators
Principal Investigator: Harold L Lazar MD Boston Medical Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Harold L. Lazar MD, Professor of Cardiothoracic Surgery, American Heart Association
ClinicalTrials.gov Identifier: NCT00460499     History of Changes
Other Study ID Numbers: H-23735
First Posted: April 16, 2007    Key Record Dates
Last Update Posted: June 23, 2015
Last Verified: June 2015

Keywords provided by Harold L. Lazar MD, American Heart Association:
Diabetes

Additional relevant MeSH terms:
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs