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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Inova Health Care Services
ClinicalTrials.gov Identifier:
NCT01033916
First received: December 16, 2009
Last updated: February 19, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Blood Glucose
Coronary Artery Bypass
Insulin
Coronary Disease
Other: LIBERAL

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Strict or Liberal Insulin Protocol Following Coronary Artery Bypass Graft (CABG) Surgery

Resource links provided by NLM:


Further study details as provided by Inova Health Care Services:

Primary Outcome Measures:
  • 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. [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The second pre-specified endpoint will be all-cause mortality at 90 days. [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: December 2009
Estimated Study Completion Date: December 2014
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01033916

Locations
United States, Virginia
Inova Fairfax Hospital
Falls Church, Virginia, United States, 22042
Sponsors and Collaborators
Inova Health Care Services
Investigators
Principal Investigator: Niv Ad, MD Inova Heart & Vascular Institute
  More Information

No publications provided

Responsible Party: Inova Health Care Services
ClinicalTrials.gov Identifier: NCT01033916     History of Changes
Other Study ID Numbers: SLIP - 09.111
Study First Received: December 16, 2009
Last Updated: February 19, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Inova Health Care Services:
Blood Glucose
Insulin/Administration and Dosage
Coronary Artery Bypass

Additional relevant MeSH terms:
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014