Outcomes Study of Hyperinsulinemic Glucose Control in Cardiac Surgery

NeuroTherapia, Inc.

Status: Completed

Conditions: Cardiac Surgery

Treatments: Other: insulin at the standard of care levels; Other: Hyperinsulinemic-normoglycemic clamp

Study type: Interventional

Funder types: Other

Identifiers

NCT00524472

07-470

Details and patient eligibility

About

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 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.

Enrollment: 1,439 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,439 participants in 2 patient groups

Hyperinsulinemic-normoglycemic clamp

Experimental group

Description:

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

Treatment:

Other: Hyperinsulinemic-normoglycemic clamp

Insulin at the standard of care levels

Other group

Description:

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

Treatment:

Other: insulin at the standard of care levels