Outcomes Study of Hyperinsulinemic Glucose Control in Cardiac Surgery

Overview

Patients undergoing cardiac surgery will be randomized into one of two groups. Group A will be administered insulin using the hyperinsulinemic-normoglycemic clamp to normalize blood glucose levels intra-operatively. Group B will be administered insulin at the standard of care levels established by the participating institution. Patients will be followed at 10 days, 15 days and one year post-operatively.

Full Title of Study: “The Effect of Hyperinsulinemic Glucose Control on Outcomes Following Cardiac Surgery”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Single (Participant)
  • Study Primary Completion Date: April 2015

Detailed Description

Using a randomized, controlled design, we propose to test the primary hypothesis that normalization of blood glucose using a hyperinsulinemic-normoglycemic clamp technique reduces the risk of a composite outcome (one or more) of 30-day postoperative mortality and serious postoperative cardiac, renal, neurologic, and infectious postoperative complications in patients undergoing cardiac surgery. Our secondary hypothesis is that hyperinsulinemic normoglycemic therapy will reduce length of stay in intensive care unit, atrial dysrhythmias, creatinine elevation, hospital readmission, all-cause and cardiac one-year mortality.

Interventions

  • Other: Hyperinsulinemic-normoglycemic clamp
    • Patients will be randomized to receive the hyperinsulinemic-normoglycemic clamp titrating the blood glucose to 80-110 mg/dL.
  • Other: insulin at the standard of care levels
    • Subjects will be administered insulin at the standard of care levels established by the participating institution.

Arms, Groups and Cohorts

  • Experimental: Hyperinsulinemic-normoglycemic clamp
    • Patients will be randomized to receive the hyperinsulinemic-normoglycemic clamp titrating the blood glucose to 80-110 mg/dL.
  • Other: Insulin at the standard of care levels
    • Group B will be administered insulin at the standard of care levels established by the participating institution.

Clinical Trial Outcome Measures

Primary Measures

  • Any Major Morbidity/30-day Mortality
    • Time Frame: within 30 days post surgery
    • a composite (any versus none) of the following major postoperative complications occurring: all-cause postoperative mortality failure to wean from cardiopulmonary bypass or postoperative low cardiac index requiring mechanical circulatory support with intraaortic balloon counterpulsation, ventricular assist device, and/or extracorporeal mechanical oxygenation serious postoperative infection acute postoperative kidney injury requiring renal replacement therapy; new postoperative focal or global neurologic deficit.

Secondary Measures

  • Post Operative Atrial Fibrillation
    • Time Frame: 15 – 30 days post operative
    • Evidence suggests that maintaining intra-operative normoglycemia during cardiac surgery while providing exogenous glucose and high-dose insulin may decrease post-operative morbidity or mortality. Using a randomized, controlled design, we propose to test the primary hypothesis that normalization of blood glucose using a hyperinsulinemic-normoglycemic clamp technique reduces the risk of a composite of serious adverse outcomes in patients undergoing cardiac surgery
  • Duration of Hospitalization
    • Time Frame: starting post operative day one to discharge from hospital, on an average of 8 days
    • Days from date of surgery to hospital discharge
  • Duration of Intensive Care Stay
    • Time Frame: ICU stay hours during hospital stay after surgery, on average of 25 hours
    • Hours from date of surgery to discharge from intensive care unit
  • All-cause Mortality
    • Time Frame: one year post operative
    • All-cause mortality identified during one-year follow-up.
  • a Composite of Minor Postoperative Complications
    • Time Frame: within 30 days after surgery
    • a composite of minor postoperative complications, which includes: a) prolonged mechanical ventilation, b) low cardiac index, c) acute kidney injury, d) prolonged hospitalization, and 3) all-cause hospital readmission within 30 days.

Participating in This Clinical Trial

Inclusion Criteria

  • Age 18-90 years old – Scheduled for cardiac surgery requiring cardiopulmonary bypass Exclusion Criteria:

  • Off-pump surgical procedures – Anticipated deep hypothermic circulatory arrest – In available, baseline cardiac troponin I (>0.5 ng/L) or troponin T (> 0.1 ng/mL) levels (at RVH or CC, respectively) – Any contraindications to the proposed interventions – Active infection, including patients with endocarditis or infected pacemaker leads. – Any infection requiring long- term antibiotics ( > 14 days) – kidney disease requiring renal replacement therapy

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • The Cleveland Clinic
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Andra I Duncan, M.D., Principal Investigator, The Cleveland Clinic
    • Daniel I Sessler, M.D., Study Director, The Cleveland Clinic
    • Thomas Schricker, MD, Principal Investigator, Royal Victoria Hospital, Montreal, Canada
    • George Carvalho, MD, Principal Investigator, Royal Victoria Hospital, Montreal, Canada

Citations Reporting on Results

Albacker TB, Carvalho G, Schricker T, Lachapelle K. Myocardial protection during elective coronary artery bypass grafting using high-dose insulin therapy. Ann Thorac Surg. 2007 Dec;84(6):1920-7; discussion 1920-7. doi: 10.1016/j.athoracsur.2007.07.001.

Duncan AE, Kateby Kashy B, Sarwar S, Singh A, Stenina-Adognravi O, Christoffersen S, Alfirevic A, Sale S, Yang D, Thomas JD, Gillinov M, Sessler DI. Hyperinsulinemic Normoglycemia Does Not Meaningfully Improve Myocardial Performance during Cardiac Surgery: A Randomized Trial. Anesthesiology. 2015 Aug;123(2):272-87. doi: 10.1097/ALN.0000000000000723.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.