Strict or Liberal Insulin Protocol Following Coronary Artery Bypass Graft (CABG) Surgery

NCT01033916 | Completed

• 1 other identifier: SLIP - 09.111
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This research study is designed to better understand post-operative complications as related to the tightness of blood sugar control. It is also hoped that we may learn that a more liberal control of your blood sugars is not inferior to the current strict glucose control. Our ultimate goal is to evaluate if there is any change in the rates of complications between the two groups. We will be comparing the current strict blood glucose control with a more liberal target for blood sugars.

Conditions

Blood Glucose; Coronary Artery Bypass; Insulin; Coronary Disease

Keywords

Blood Glucose; Insulin/Administration and Dosage; Coronary Artery Bypass

Outcome Measures

Primary Outcomes (1)

• Operative death, major adverse cardiac events (death, myocardial infarction, re-vascularization), re-operation, Cerebrovascular accident, Deep Sternal Wound Infection, Prolonged Ventilatory Support, Acute Renal Failure, and prolonged inotropic support.

  30 days

Secondary Outcomes (1)

• The second pre-specified endpoint will be all-cause mortality at 90 days.

  90 days

Study Arms (2)

STRICT Glucose Control (80-120 mg/dL)

NO INTERVENTION

The STRICT arm of the study will have a target Blood Glucose level ranging from 80-120 mg/dL. This is currently the standard of care for post CABG patients.

LIBERAL (Target Glucose:121-180 mg/dL)

ACTIVE COMPARATOR

Other: LIBERAL

Interventions

LIBERAL OTHER

The LIBERAL arm of the study will have a target Blood Glucose level ranging from 121-180 mg/dL. As opposed to the standard of less than 120 mg/dL.

LIBERAL (Target Glucose:121-180 mg/dL)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All diabetic patients going for isolated, non-emergent CABG surgery at Inova Fairfax Hospital (IFH).
• Non diabetic patients going for isolated, non-emergent CABG Surgery at IFH that are found to have a finger stick blood glucose \> 150 mg/dl, either pre-operative, during the procedure or post-operatively.

You may not qualify if:

• Patients that are not undergoing CABG surgery.
• Patients that post-CABG surgery are not on an insulin infusion.
• Patients that are undergoing other procedures in addition to CABG will be excluded. (ie. CABG + valve repair)

Sponsors & Collaborators

• Inova Health Care Services: lead

Study Sites (1)

Inova Fairfax Hospital

Falls Church, Virginia, 22042, United States

Location

MeSH Terms

Conditions

Insulin Resistance; Coronary Disease

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Niv Ad, MD

  Inova Heart & Vascular Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2009
• First Posted: December 17, 2009
• Study Start: December 1, 2009
• Primary Completion: April 30, 2011
• Study Completion: July 30, 2016
• Last Updated: January 6, 2022

Record last verified: 2022-01

Locations

US (1)