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

June 22, 2015 updated by: Harold L. Lazar MD, American Heart Association
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

250

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 88 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diabetic CABG patients

Exclusion Criteria:

  • Renal and hepatic failure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
glycemic control, postoperative morbidity, inflammatory markers
Time Frame: 24 hours following surgery
24 hours following surgery
glycemic control
Time Frame: 24 hours following surgery
24 hours following surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
free fatty acid levels
Time Frame: 24 hours following surgery
24 hours following surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

American Heart Association

Investigators

  • Principal Investigator: Harold L Lazar MD, Boston Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2004

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

April 12, 2007

First Submitted That Met QC Criteria

April 12, 2007

First Posted (Estimate)

April 16, 2007

Study Record Updates

Last Update Posted (Estimate)

June 23, 2015

Last Update Submitted That Met QC Criteria

June 22, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-23735

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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