Improving Outcomes In Diabetic Patients During CABG Surgery By Optimizing Glycemic Control
NCT ID: NCT00460499
Last Updated: 2015-06-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
250 participants
INTERVENTIONAL
2004-07-31
2015-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
SINGLE
Study Groups
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B Low dose GIK
This group will have low doses of glucose and insulin
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 have high doses of insulin and glucose
C High Dose GIK
This group will receive D20W+160units IV insulin to keep blood sugar between 120-180mg/dl
A Insulin
This group will receive only an intravenous insulin infusion
A IV Insulin drip
These patients will receive 100units of insulin in 100ml of saline intravenously to keep blood glucose between 120-180mg/dl.
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
90 Years
ALL
No
Sponsors
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American Heart Association
OTHER
Responsible Party
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Harold L. Lazar MD
Professor of Cardiothoracic Surgery
Principal Investigators
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Harold L Lazar MD
Role: PRINCIPAL_INVESTIGATOR
Boston Medical Center
Locations
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Boston Medical Center
Boston, Massachusetts, United States
Countries
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References
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Bellon F, Sola I, Gimenez-Perez G, Hernandez M, Metzendorf MI, Rubinat E, Mauricio D. Perioperative glycaemic control for people with diabetes undergoing surgery. Cochrane Database Syst Rev. 2023 Aug 1;8(8):CD007315. doi: 10.1002/14651858.CD007315.pub3.
Lazar HL, McDonnell MM, Chipkin S, Fitzgerald C, Bliss C, Cabral H. Effects of aggressive versus moderate glycemic control on clinical outcomes in diabetic coronary artery bypass graft patients. Ann Surg. 2011 Sep;254(3):458-63; discussion 463-4. doi: 10.1097/SLA.0b013e31822c5d78.
Other Identifiers
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H-23735
Identifier Type: -
Identifier Source: org_study_id
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