Outcomes Study of Hyperinsulinemic Glucose Control in Cardiac Surgery

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1439 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2015-04-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Cardiac Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Hyperinsulinemic-normoglycemic clamp

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

Group Type EXPERIMENTAL

Hyperinsulinemic-normoglycemic clamp

Intervention Type OTHER

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

Insulin at the standard of care levels

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

Group Type OTHER

insulin at the standard of care levels

Intervention Type OTHER

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

Interventions

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Hyperinsulinemic-normoglycemic clamp

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

Intervention Type OTHER

insulin at the standard of care levels

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

Intervention Type OTHER

Other Intervention Names

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clamp Hyperinsulinemic insulin

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No