Trial Outcomes & Findings for Outcomes Study of Hyperinsulinemic Glucose Control in Cardiac Surgery (NCT NCT00524472)

NCT ID: NCT00524472

Last Updated: 2018-10-26

Results Overview

a composite (any versus none) of the following major postoperative complications occurring: 1. all-cause postoperative mortality 2. 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 3. serious postoperative infection 4. acute postoperative kidney injury requiring renal replacement therapy; 5. new postoperative focal or global neurologic deficit.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 1439 participants
• Primary outcome timeframe: within 30 days post surgery
• Results posted on: 2018-10-26

Participant Flow

Participant milestones

Measure	Hyperinsulinemic-normoglycemic Clamp Patients will be randomized to receive the hyperinsulinemic-normoglycemic clamp titrating the blood glucose to 80-110 mg/dL. 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 Group B will be administered insulin at the standard of care levels established by the participating institution. insulin at the standard of care levels: Subjects will be administered insulin at the standard of care levels established by the participating institution.
Overall Study STARTED	709	730
Overall Study COMPLETED	709	730
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Outcomes Study of Hyperinsulinemic Glucose Control in Cardiac Surgery

Baseline characteristics by cohort

Measure	Hyperinsulinemic-normoglycemic Clamp n=709 Participants Patients will be randomized to receive the hyperinsulinemic-normoglycemic clamp titrating the blood glucose to 80-110 mg/dL. 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 n=730 Participants Group B will be administered insulin at the standard of care levels established by the participating institution. insulin at the standard of care levels: Subjects will be administered insulin at the standard of care levels established by the participating institution.	Total n=1439 Participants Total of all reporting groups
Age, Continuous	66 years STANDARD_DEVIATION 11 • n=5 Participants	66 years STANDARD_DEVIATION 11 • n=7 Participants	66 years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	189 Participants n=5 Participants	184 Participants n=7 Participants	373 Participants n=5 Participants
Sex: Female, Male Male	520 Participants n=5 Participants	546 Participants n=7 Participants	1066 Participants n=5 Participants
Region of Enrollment Canada	457 Participants n=5 Participants	464 Participants n=7 Participants	921 Participants n=5 Participants
Region of Enrollment United States	252 Participants n=5 Participants	266 Participants n=7 Participants	518 Participants n=5 Participants

PRIMARY outcome

Timeframe: within 30 days post surgery

a composite (any versus none) of the following major postoperative complications occurring:

1. all-cause postoperative mortality

2. 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

3. serious postoperative infection

4. acute postoperative kidney injury requiring renal replacement therapy;

5. new postoperative focal or global neurologic deficit.

Outcome measures

Measure	Hyperinsulinemic-normoglycemic Clamp n=709 Participants Patients will be randomized to receive the hyperinsulinemic-normoglycemic clamp titrating the blood glucose to 80-110 mg/dL. 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 n=730 Participants Group B will be administered insulin at the standard of care levels established by the participating institution. insulin at the standard of care levels: Subjects will be administered insulin at the standard of care levels established by the participating institution.
Any Major Morbidity/30-day Mortality	46 Participants	82 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Hyperinsulinemic-normoglycemic Clamp n=709 Participants Patients will be randomized to receive the hyperinsulinemic-normoglycemic clamp titrating the blood glucose to 80-110 mg/dL. 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 n=730 Participants Group B will be administered insulin at the standard of care levels established by the participating institution. insulin at the standard of care levels: Subjects will be administered insulin at the standard of care levels established by the participating institution.
Post Operative Atrial Fibrillation	209 Participants	235 Participants

SECONDARY outcome

Timeframe: starting post operative day one to discharge from hospital, on an average of 8 days

Days from date of surgery to hospital discharge

Outcome measures

Measure	Hyperinsulinemic-normoglycemic Clamp n=686 Participants Patients will be randomized to receive the hyperinsulinemic-normoglycemic clamp titrating the blood glucose to 80-110 mg/dL. 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 n=713 Participants Group B will be administered insulin at the standard of care levels established by the participating institution. insulin at the standard of care levels: Subjects will be administered insulin at the standard of care levels established by the participating institution.
Duration of Hospitalization	8 days Interval 6.0 to 12.0	8 days Interval 6.0 to 12.0

SECONDARY outcome

Timeframe: ICU stay hours during hospital stay after surgery, on average of 25 hours

Hours from date of surgery to discharge from intensive care unit

Outcome measures

Measure	Hyperinsulinemic-normoglycemic Clamp n=649 Participants Patients will be randomized to receive the hyperinsulinemic-normoglycemic clamp titrating the blood glucose to 80-110 mg/dL. 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 n=671 Participants Group B will be administered insulin at the standard of care levels established by the participating institution. insulin at the standard of care levels: Subjects will be administered insulin at the standard of care levels established by the participating institution.
Duration of Intensive Care Stay	25 hours Interval 24.9 to 26.3	27 hours Interval 25.2 to 27.3

SECONDARY outcome

Timeframe: one year post operative

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

Outcome measures

Measure	Hyperinsulinemic-normoglycemic Clamp n=653 Participants Patients will be randomized to receive the hyperinsulinemic-normoglycemic clamp titrating the blood glucose to 80-110 mg/dL. 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 n=682 Participants Group B will be administered insulin at the standard of care levels established by the participating institution. insulin at the standard of care levels: Subjects will be administered insulin at the standard of care levels established by the participating institution.
All-cause Mortality	32 Participants	22 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Hyperinsulinemic-normoglycemic Clamp n=709 Participants Patients will be randomized to receive the hyperinsulinemic-normoglycemic clamp titrating the blood glucose to 80-110 mg/dL. 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 n=730 Participants Group B will be administered insulin at the standard of care levels established by the participating institution. insulin at the standard of care levels: Subjects will be administered insulin at the standard of care levels established by the participating institution.
a Composite of Minor Postoperative Complications	200 Participants	237 Participants

Adverse Events

Hyperinsulinemic-normoglycemic Clamp

Serious events: 18 serious events

Other events: 0 other events

Deaths: 32 deaths

Insulin at the Standard of Care Levels

Serious events: 27 serious events

Other events: 0 other events

Deaths: 22 deaths

Serious adverse events

Measure	Hyperinsulinemic-normoglycemic Clamp n=709 participants at risk Patients will be randomized to receive the hyperinsulinemic-normoglycemic clamp titrating the blood glucose to 80-110 mg/dL. 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 n=730 participants at risk Group B will be administered insulin at the standard of care levels established by the participating institution. insulin at the standard of care levels: Subjects will be administered insulin at the standard of care levels established by the participating institution.
Surgical and medical procedures sae	2.5% 18/709 • Number of events 18 • One Year Post-opeperative follow-up for All-Cause Mortality; 1 month Post-opeperative follow-up for Serious Adverse Events and Other (Not Including Serious) Adverse Events	3.7% 27/730 • Number of events 27 • One Year Post-opeperative follow-up for All-Cause Mortality; 1 month Post-opeperative follow-up for Serious Adverse Events and Other (Not Including Serious) Adverse Events

Other adverse events

Adverse event data not reported

Additional Information

Andra Duncan, MD

Cleveland Clinic

Phone: 216 445-2372

Email: DUNCANA@ccf.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place