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

NCT ID: NCT00460499

Last Updated: 2015-06-23

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Study Completion Date

2015-03-31

Brief Summary

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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

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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.

Conditions

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Glycemic Control

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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B Low dose GIK

This group will have low doses of glucose and insulin

Group Type ACTIVE_COMPARATOR

B Low Dose GIK

Intervention Type DRUG

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

Group Type ACTIVE_COMPARATOR

C High Dose GIK

Intervention Type DRUG

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

Group Type ACTIVE_COMPARATOR

A IV Insulin drip

Intervention Type DRUG

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.

Intervention Type DRUG

B Low Dose GIK

These patients will receive D5W+80unitsInsulin+40mEqKCL IV to keep blood glucose between 120-180mg/dl

Intervention Type DRUG

C High Dose GIK

This group will receive D20W+160units IV insulin to keep blood sugar between 120-180mg/dl

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diabetic CABG patients

Exclusion Criteria

* Renal and hepatic failure
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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American Heart Association

OTHER

Sponsor Role lead

Responsible Party

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Harold L. Lazar MD

Professor of Cardiothoracic Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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United States

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.

Reference Type DERIVED
PMID: 37526194 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21865944 (View on PubMed)

Other Identifiers

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H-23735

Identifier Type: -

Identifier Source: org_study_id

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