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Completed

NCT Number: NCT00524472

Outcomes Study of Hyperinsulinemic Glucose Control in Cardiac Surgery

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.

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Key information

Conditions

Cardiac Surgery

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal Victoria Hospital, Montreal, Quebec, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hyperinsulinemic-normoglycemic clamp

Other

Patients will be randomized to receive the hyperinsulinemic-normoglycemic clamp titrating the blood glucose to 80-110 mg/dL.

Other names: clamp, Hyperinsulinemic

insulin at the standard of care levels

Other

Subjects will be administered insulin at the standard of care levels established by the participating institution.

Other names: insulin

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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

  3. 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

  4. All-cause Mortality

    Time frame: one year post operative

    All-cause mortality identified during one-year follow-up.

  5. 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.

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Official study title

The Effect of Hyperinsulinemic Glucose Control on Outcomes Following Cardiac Surgery

Important dates

Study start
2007
Primary completion
2015
Study completion
2015
First posted
Sep 3, 2007
Registry last updated
Oct 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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