Aggressive Versus Moderate Glycemic Control in Diabetic Coronary Bypass Patients

NCT ID: NCT00576394

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2015-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

entGlycemic control has been found to improve clinical outcomes following Coronary Bypass Surgery. This study tests the hypothesis that obtaining tighter glycemic control(80-120mg/dl) as opposed to more moderate control (120-180mg/dl) will further improve outcomes.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

150 diabetic patients will be randomized to achieve aggressive glycemic control (80-120mg/dl) vs moderate control (120-180mg/dl) using intravenous insulin infusions beginning at anesthetic induction and continuing for 18 hours following surgery.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Glycemic Control

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1Moderate Glycemic Control

Patients will receive an insulin drip to keep blood glucose levels between 120-180mg/dl

Group Type ACTIVE_COMPARATOR

IV Insulin drip

Intervention Type DRUG

IV insulin drip at 100units insulin in 100ml saline designed to keep blood glucose between 120-180mg/dl

2Aggressive Glycemic Control

Patients will receive an insulin drip designed to maintain serum glucose between 80-120mg/dl

Group Type ACTIVE_COMPARATOR

Insulin

Intervention Type DRUG

IV insulin drip to keep serum glucose between 80-120mg/dl.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

IV Insulin drip

IV insulin drip at 100units insulin in 100ml saline designed to keep blood glucose between 120-180mg/dl

Intervention Type DRUG

Insulin

IV insulin drip to keep serum glucose between 80-120mg/dl.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* All diabetic patients undergoing Coronary Bypass Surgery

Exclusion Criteria

* Patients with hepatic and renal failure
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Eli Lilly and Company

INDUSTRY

Sponsor Role collaborator

American Heart Association

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Harold L. Lazar MD

Professor of Cardiothoracic Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Boston Medical Center

Boston, Massachusetts, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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 RESULT
PMID: 21865944 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

H-25760

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Insulin Balanced Infusion System
NCT01291719 ACTIVE_NOT_RECRUITING PHASE1/PHASE2
Post-Gastric Bypass Hypoglycemia
NCT01933490 COMPLETED NA
Exenatide for Stress Hyperglycemia
NCT01969149 COMPLETED PHASE2/PHASE3