Intensive Insulin Therapy in Patients Undergoing Coronary Artery Bypass Surgery

NCT01361594 | Completed Phase 3 Results DMC

• 2 other identifiers: IRB0004835600048356-2010
• Study Type: interventional
• Target: 338
• Locations: 1 country
• Sites: 1

Brief Summary

High blood glucose levels (hyperglycemia) in cardiac surgery patients with diabetes are associated with increased risk of hospital complications. Blood sugar control with intravenous insulin may prevent such hospital complications. Many patients undergoing cardiac bypass surgery (CABG) develop high blood sugars and require insulin therapy (shortly before or after surgery). It is not clear what the best insulin regimen is or what is the best blood sugar target in these patients. Accordingly, this research study aims to determine optimal blood glucose levels during the in patients undergoing cardiac bypass surgery. Patients will be divided in two groups. The intensive insulin group will be maintained at blood glucose between 100-140 mg/dl and the conventional treatment group at a glucose level between 140-180 mg/dl. The insulins to be used in this trial (lantus, aspart and regular insulin) are approved for use in the treatment of patients with diabetes by the FDA (Food and Drug Administration). A total of 326 patients with high blood glucose after cardiac bypass surgery will be recruited in this study. Patients will be recruited at Emory University Hospital, Emory Midtown Hospital and Grady Memorial Hospital.

Conditions

Diabetes

Keywords

Diabetes; Coronary Artery Bypass Surgery; Glycemic control; Insulin infusion

Outcome Measures

Primary Outcomes (2)

• Number of Subjects That Were Diagnosed for Peri-operative Complications

  Number of participants that presented at least 1 complications including sternal wound infection, bacteremia, acute renal failure, respiratory failure, and major cardiovascular events (MACE) during the current hospitalization and up to 6 months after hospitalization

  Within 6 months of hospitalization

• Hospital Mortality

  Mortality is defined as death occurring during admission, either during ICU or after transition to non-ICU admission.

  average 1 month during the hospitalization

Secondary Outcomes (17)

• Glycemic Control

  average 1 month during the hospitalization

• Major Cardiovascular Events

  average 1 month during the hospitalization

• Acute Renal Failure

  average 1 month during the hospitalization

• Respiratory Failure, Defined as PaO2 Value < 60 mm Hg While Breathing Air or a PaCO2 > 50 mm Hg.

  average 1 month during the hospitalization

• ICU and Hospital Length of Stay, and ICU Readmissions

  average 1 month during the hospitalization

Study Arms (2)

Intensive insulin treatment

ACTIVE COMPARATOR

Intensive insulin treatment (BG target: 100-140 mg/dL)

Other: Regular insulin (intensive treatment)

Conventional insulin treatment

ACTIVE COMPARATOR

Conventional insulin treatment (BG target: 141-180 mg/dl)

Other: Regular Insulin (conventional treatment)

Interventions

Regular insulin (intensive treatment) OTHER

Titration of the IV insulin rate for glucose goal 100-140 mg/dL

Intensive insulin treatment

Regular Insulin (conventional treatment) OTHER

Titration of the IV insulin rate for glucose goal 141-180 mg/dl

Conventional insulin treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females between the ages of 18 and 80 years undergoing CABG +/- valve surgery.
• Post surgical hyperglycemia (BG \> 140 mg/dl).
• Patients with and without a history of type 2 diabetes

You may not qualify if:

• Patients requiring combination CABG with additional procedures such aorta replacement.
• Patients with severely impaired renal function (serum creatinine ≥3.0 mg/dl or GFR \< 30 ml/min) or clinically significant hepatic failure.
• Subjects with acute hyperglycemic crises such as diabetic ketoacidosis (DKA) and hyperosmolar hyperglycemic state.
• Moribund patients and those at imminent risk of death (brain death or cardiac standstill).
• Patients or next-to-kin with mental condition rendering the subject or family member unable to understand the nature, scope, and possible consequences of the study.
• Female subjects who are pregnant or breast-feeding at time of enrollment into the study.

Sponsors & Collaborators

• Emory University: lead
• American Diabetes Association: collaborator

Study Sites (1)

Emory University Hospital

Atlanta, Georgia, 30326, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Insulin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Dr. Guillermo Umpierrez
• Organization: Emory University

geumpie@emory.edu

404-778-1665

Study Officials

• Guillermo E Umpierrez, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: February 3, 2011
• First Posted: May 27, 2011
• Study Start: June 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: December 31, 2014
• Results First Posted: December 31, 2014

Record last verified: 2014-12

Locations

US (1)