Clinical trial NCT00524472: Outcomes Study of Hyperinsulinemic Glucose Control in Cardiac Surgery
Official title: The Effect of Hyperinsulinemic Glucose Control on Outcomes Following Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Surgery
Keywords: Hyperinsulinemic glucose control
cardiac surgery
Outcome
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2007-09-03
Enrollment: 1439
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Any Major Morbidity/30-day Mortality
timeFrame: within 30 days post surgery
Secondary outcomes:
measure: Post Operative Atrial Fibrillation
timeFrame: 15 - 30 days post operative
measure: Duration of Hospitalization
timeFrame: starting post operative day one to discharge from hospital, on an average of 8 days
measure: Duration of Intensive Care Stay
timeFrame: ICU stay hours during hospital stay after surgery, on average of 25 hours
measure: All-cause Mortality
timeFrame: one year post operative
measure: a Composite of Minor Postoperative Complications
timeFrame: within 30 days after surgery
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Montreal
country: Canada
facility: Royal Victoria Hospital
state: Quebec
Study officials:
affiliation: The Cleveland Clinic
name: Andra I Duncan, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: The Cleveland Clinic
name: Daniel I Sessler, M.D.
role: STUDY_DIRECTOR
affiliation: Royal Victoria Hospital, Montreal, Canada
name: Thomas Schricker, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Royal Victoria Hospital, Montreal, Canada
name: George Carvalho, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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: A Randomized Trial. Anesthesiology. 2015 Aug;123(2):272-87. doi: 10.1097/ALN.0000000000000723.
citation: Schricker T, Sato H, Beaudry T, Codere T, Hatzakorzian R, Pruessner JC. Intraoperative maintenance of normoglycemia with insulin and glucose preserves verbal learning after cardiac surgery. PLoS One. 2014 Jun 18;9(6):e99661. doi: 10.1371/journal.pone.0099661. eCollection 2014.