NCT00576394

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Oct 2006

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

December 18, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 19, 2007

Completed
7.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

June 23, 2015

Status Verified

June 1, 2015

Enrollment Period

8.7 years

First QC Date

December 18, 2007

Last Update Submit

June 22, 2015

Conditions

Glycemic Control

Keywords

Glucose, Insulin

Outcome Measures

Primary Outcomes (1)

  • Incidence of Hypoglycemia

    24 hours following surgery

Secondary Outcomes (1)

  • free fatty acid levels

    24 hours following surgery

Study Arms (2)

1Moderate Glycemic Control

ACTIVE COMPARATOR

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

Drug: IV Insulin drip

2Aggressive Glycemic Control

ACTIVE COMPARATOR

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

Drug: Insulin

Interventions

IV Insulin dripDRUG

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

1Moderate Glycemic Control
InsulinDRUG

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

2Aggressive Glycemic Control

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All diabetic patients undergoing Coronary Bypass Surgery

You may not qualify if:

  • Patients with hepatic and renal failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Related Publications (1)

  • 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.

    PMID: 21865944RESULT

MeSH Terms

Conditions

Insulin Resistance

Interventions

Insulin

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

ProinsulinInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Cardiothoracic Surgery

Study Record Dates

First Submitted

December 18, 2007

First Posted

December 19, 2007

Study Start

October 1, 2006

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

June 23, 2015

Record last verified: 2015-06

Locations

US(1)