Outcomes Study of Hyperinsulinemic Glucose Control in Cardiac Surgery

Cardiac Surgery Clinical Trial

Official title:

The Effect of Hyperinsulinemic Glucose Control on Outcomes Following Cardiac Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00524472
• Other study ID #: 07-470
• Status: Completed
• Phase: N/A
• Start date: July 2007
• Est. completion date: April 2015

Study information

• Verified date: February 2018
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1439
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Surgery

Intervention

Other:
• Hyperinsulinemic-normoglycemic clamp
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
Subjects will be administered insulin at the standard of care levels established by the participating institution.

Locations

Country	Name	City	State
Canada	Royal Victoria Hospital	Montreal	Quebec
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (2)

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. — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Any Major Morbidity/30-day Mortality	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.	within 30 days post surgery
Secondary	Post Operative Atrial Fibrillation	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	15 - 30 days post operative
Secondary	Duration of Hospitalization	Days from date of surgery to hospital discharge	starting post operative day one to discharge from hospital, on an average of 8 days
Secondary	Duration of Intensive Care Stay	Hours from date of surgery to discharge from intensive care unit	ICU stay hours during hospital stay after surgery, on average of 25 hours
Secondary	All-cause Mortality	All-cause mortality identified during one-year follow-up.	one year post operative
Secondary	a Composite of Minor Postoperative Complications	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.	within 30 days after surgery