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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Disease; Coronary Artery Bypass; Blood Glucose; Insulin
• Intervention / Treatment: Other: LIBERAL

Detailed Description

Hyperglycemia is commonly encountered following cardiac surgery, whether a patient has a history of diabetes or not. Hyperglycemia has been associated with increased perioperative morbidity and mortality; several studies have demonstrated that glycemic control utilizing insulin protocols improves operative mortality, lowers operative morbidity (mediastinitis, atrial fibrillation), and improves long-term survival. However, the optimal target for serum glucose has not been established in post-CABG patients.

Methods:

All CABG patients will be consented prior to surgery. Inclusion criteria for non-diabetic patient is a random fingerstick blood glucose (FSBG) above >150 mg/dL prior, during, or immediately following surgery. All patients with history of diabetes mellitus (Type 1 or Type II) will be immediately eligible for inclusion.

Following CABG surgery, if the patient was started intra-operatively on an insulin infusion, then that patient will be randomized to one of two treatment target groups: Group 1 [Blood Glucose (BG): 80 mg/dL-120 mg/dL] or Group 2 [BG: 121-180 mg/dL]. The randomization design will be a 1:1 allocation of patients between the two groups, with both diabetic and non-diabetic patients enrolled in both arms of the study. Patients will be maintained on an electronic-based protocol of intravenous insulin for a minimum of 72 hrs postoperatively. Patients remaining in the CVICU greater than 72 hrs will have their intravenous insulin continued until transfer to the step-down unit.

The Glucommander© will be programmed to adjust the insulin drip to one of these two target groups. The nursing staff will not be blinded to treatment group allocation. The primary endpoint with be a composite of operative death, major adverse cardiac events (MACE: death, myocardial infarction, re-vascularization), STS Defined Major Morbidity (re-operation, Cerebrovascular accident, Deep Sternal Wound Infection/Mediastinitis, Prolonged Ventilatory Support (> 24 hrs), Acute Renal Failure), and prolonged inotropic support. The pre-specified sub-group analysis will compare perioperative outcome of patients with diabetes vs non-diabetic patients.

Hypothesis:

Our hypothesis is that the perioperative outcome of Group 2 [BG: 121 - 180 mg/dL] will not be inferior to Group 1 [BG: 80-120 mg/dL]. We anticipate significantly more hypoglycemic events in Group 1.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Falls Church, Virginia, United States, 22042
      • Inova Fairfax Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. All diabetic patients going for isolated, non-emergent CABG surgery at Inova Fairfax Hospital (IFH).
2. 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.
3. Those patients that meet Inclusion Criteria #1 OR #2 AND have been started on an insulin infusion while in the operative room will be enrolled.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: STRICT Glucose Control (80-120 mg/dL); 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.
Active Comparator: LIBERAL (Target Glucose:121-180 mg/dL)	Other: LIBERAL; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
The second pre-specified endpoint will be all-cause mortality at 90 days.	90 days

Collaborators and Investigators

• Sponsor: Inova Health Care Services
• Investigators: Principal Investigator: Niv Ad, MD, Inova Heart & Vascular Institute

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2009
• Primary Completion (Actual): April 30, 2011
• Study Completion (Actual): July 30, 2016

Study Registration Dates

• First Submitted: December 16, 2009
• First Submitted That Met QC Criteria: December 16, 2009
• First Posted (Estimate): December 17, 2009

Study Record Updates

• Last Update Posted (Actual): January 6, 2022
• Last Update Submitted That Met QC Criteria: January 5, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Blood Glucose; Coronary Artery Bypass; Insulin/Administration and Dosage
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Disease
• Other Study ID Numbers: SLIP - 09.111