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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Harold L. Lazar MD, American Heart Association
ClinicalTrials.gov Identifier:
NCT00460499
First received: April 12, 2007
Last updated: July 17, 2012
Last verified: July 2012
  Purpose

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 Intervention Phase
Glycemic Control
Drug: A IV Insulin drip
Drug: B Low Dose GIK
Drug: C High Dose GIK
Phase 1

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

Resource links provided by NLM:


Further study details as provided by American Heart Association:

Primary Outcome Measures:
  • glycemic control, postoperative morbidity, inflammatory markers [ Time Frame: 24 hours following surgery ] [ Designated as safety issue: No ]
  • glycemic control [ Time Frame: 24 hours following surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • free fatty acid levels [ Time Frame: 24 hours following surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 410
Study Start Date: July 2004
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diabetic CABG patients

Exclusion Criteria:

  • Renal and hepatic failure
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by American Heart Association

Additional 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
Study First Received: April 12, 2007
Last Updated: July 17, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by American Heart Association:
Diabetes

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

ClinicalTrials.gov processed this record on November 20, 2014