Trial Outcomes & Findings for Intensive Insulin Therapy in Patients Undergoing Coronary Artery Bypass Surgery (NCT NCT01361594)

Results Overview

Number of participants that presented at least 1 complications including sternal wound infection, bacteremia, acute renal failure, respiratory failure, and major cardiovascular events (MACE) during the current hospitalization and up to 6 months after hospitalization

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

338 participants

Primary outcome timeframe

Within 6 months of hospitalization

Results posted on

2014-12-31

Participant Flow

Emory University Hospital, Emory University Hospital - Midtown and Grady Hospital

Patients undergoing coronary artery bypass surgery (CABG) that develop hyperglycemia (defined as a blood glucose \>140) intraoperatively or in an intenstive care unit (ICU) post-surgical procedure. 33 patients withdrawn prior to randomization, due to various reasons, including surgery cancellation, transportation to a different hospital, etc.

Participant milestones

Participant milestones
Measure	Intensive Insulin Treatment Intensive insulin treatment (BG target: 100-140 mg/dL) Regular insulin (intensive treatment): Titration of the IV insulin rate for glucose goal 100-140 mg/dL	Conventional Insulin Treatment Conventional insulin treatment (BG target: 141-180 mg/dl) Regular Insulin (conventional treatment): Titration of the IV insulin rate for glucose goal 141-180 mg/dl
Overall Study STARTED	152	153
Overall Study COMPLETED	151	151
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Intensive Insulin Treatment Intensive insulin treatment (BG target: 100-140 mg/dL) Regular insulin (intensive treatment): Titration of the IV insulin rate for glucose goal 100-140 mg/dL	Conventional Insulin Treatment Conventional insulin treatment (BG target: 141-180 mg/dl) Regular Insulin (conventional treatment): Titration of the IV insulin rate for glucose goal 141-180 mg/dl
Overall Study Withdrawal by Subject	1	2

Baseline Characteristics

Intensive Insulin Therapy in Patients Undergoing Coronary Artery Bypass Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intensive Insulin Treatment n=151 Participants Intensive insulin treatment (BG target: 100-140 mg/dL) Regular insulin (intensive treatment): Titration of the IV insulin rate for glucose goal 100-140 mg/dL	Conventional Insulin Treatment n=151 Participants Conventional insulin treatment (BG target: 141-180 mg/dl) Regular Insulin (conventional treatment): Titration of the IV insulin rate for glucose goal 141-180 mg/dl	Total n=302 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	79 Participants n=5 Participants	80 Participants n=7 Participants	159 Participants n=5 Participants
Age, Categorical >=65 years	72 Participants n=5 Participants	71 Participants n=7 Participants	143 Participants n=5 Participants
Sex: Female, Male Female	45 Participants n=5 Participants	39 Participants n=7 Participants	84 Participants n=5 Participants
Sex: Female, Male Male	106 Participants n=5 Participants	112 Participants n=7 Participants	218 Participants n=5 Participants

PRIMARY outcome

Timeframe: Within 6 months of hospitalization

Number of participants that presented at least 1 complications including sternal wound infection, bacteremia, acute renal failure, respiratory failure, and major cardiovascular events (MACE) during the current hospitalization and up to 6 months after hospitalization

Outcome measures

Outcome measures
Measure	Intensive Insulin Treatment n=151 Participants Intensive insulin treatment (BG target: 100-140 mg/dL) Regular insulin (intensive treatment): Titration of the IV insulin rate for glucose goal 100-140 mg/dL	Conventional Insulin Treatment n=151 Participants Conventional insulin treatment (BG target: 141-180 mg/dl) Regular Insulin (conventional treatment): Titration of the IV insulin rate for glucose goal 141-180 mg/dl
Number of Subjects That Were Diagnosed for Peri-operative Complications	58 participants	70 participants

PRIMARY outcome

Timeframe: average 1 month during the hospitalization

Mortality is defined as death occurring during admission, either during ICU or after transition to non-ICU admission.

Outcome measures

Outcome measures
Measure	Intensive Insulin Treatment n=151 Participants Intensive insulin treatment (BG target: 100-140 mg/dL) Regular insulin (intensive treatment): Titration of the IV insulin rate for glucose goal 100-140 mg/dL	Conventional Insulin Treatment n=151 Participants Conventional insulin treatment (BG target: 141-180 mg/dl) Regular Insulin (conventional treatment): Titration of the IV insulin rate for glucose goal 141-180 mg/dl
Hospital Mortality	5 participants	2 participants

SECONDARY outcome

Timeframe: average 1 month during the hospitalization

1. Hyperglycemic events (BG \> 200 mg/dL) in ICU and non-ICU 2. Hypoglycemic events (BG \< 70 mg/dl; severe hypoglycemia (BG \< 40 mg/dl).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: average 1 month during the hospitalization

1. Acute myocardial infarction : (1) typical increase and gradual decrease (troponin) or (2) more rapid increase and decrease (creatine kinase MB) of biochemical markers of myocardial necrosis with at least one of the following: (a) ischemic symptoms, (b) development of pathologic Q waves on the electrocardiogram, (c) electrocardiographic changes indicative of ischemia (ST-segment elevation or depression), or (d) coronary artery intervention (e.g., coronary angioplasty). 2. Congestive heart failure 3. Cardiac arrhythmias: malignant arrhythmia

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: average 1 month during the hospitalization

new-onset abnormal renal function: serum creatinine \> 2.0 mg/dL or an increment level \> 50% from baseline

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: average 1 month during the hospitalization

Respiratory failure, defined as PaO2 value \< 60 mm Hg while breathing air or a PaCO2 \> 50 mm Hg.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: average 1 month during the hospitalization

ICU and hospital length of stay, and ICU readmissions

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: average 1 month during the hospitalization

superficial and deep sternal wound infection

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: average 1 month during the hospitalization

Pneumonia (CDC criteria)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: average 1 month during the hospitalization

permanent stroke and reversible ischemic neurologic deficit.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: average 1 month during the hospitalization

Duration of ventilatory support and ICU readmission

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: within 30 days of discharge

Thirty day mortality

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Within 30 days after discharge

Number of hospital readmissions and emergency room visits

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: average 1 month during the hospitalization

Incidence of organ failures assessed by the daily SOFA score

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: average 1 month during the hospitalization

Measures of inflammation (C-reactive protein, TNF-alpha; IL-6) and oxidative stress markers

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: within 3 months after discharge

1. Acute myocardial infarction : (1) typical increase and gradual decrease (troponin) or (2) more rapid increase and decrease (creatine kinase MB) of biochemical markers of myocardial necrosis with at least one of the following: (a) ischemic symptoms, (b) development of pathologic Q waves on the electrocardiogram, (c) electrocardiographic changes indicative of ischemia (ST-segment elevation or depression), or (d) coronary artery intervention (e.g., coronary angioplasty). 2. Congestive heart failure 3. Cardiac arrhythmias: malignant arrhythmia

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: within 3 months after discharge

Superficial and deep sternal wound infection

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Within 3 months after discharge

Pneumonia (CDC criteria)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: within 3 months after discharge

permanent stroke and reversible ischemic neurologic deficit

Outcome measures

Outcome data not reported

Adverse Events

Intensive Insulin Treatment

Serious events: 63 serious events

Other events: 56 other events

Deaths: 0 deaths

Conventional Insulin Treatment

Serious events: 78 serious events

Other events: 50 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Intensive Insulin Treatment n=151 participants at risk Intensive insulin treatment (BG target: 100-140 mg/dL) Regular insulin (intensive treatment): Titration of the IV insulin rate for glucose goal 100-140 mg/dL	Conventional Insulin Treatment n=151 participants at risk Conventional insulin treatment (BG target: 141-180 mg/dl) Regular Insulin (conventional treatment): Titration of the IV insulin rate for glucose goal 141-180 mg/dl
Renal and urinary disorders Acute renal failure	13.9% 21/151 • Number of events 21 3 subjects that were randomized (but no intervention started) so they were not considered to be at-risk participants for adverse events.	18.5% 28/151 • Number of events 28 3 subjects that were randomized (but no intervention started) so they were not considered to be at-risk participants for adverse events.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	11.3% 17/151 • Number of events 17 3 subjects that were randomized (but no intervention started) so they were not considered to be at-risk participants for adverse events.	19.2% 29/151 • Number of events 29 3 subjects that were randomized (but no intervention started) so they were not considered to be at-risk participants for adverse events.
Respiratory, thoracic and mediastinal disorders Pneumonia	2.0% 3/151 • Number of events 3 3 subjects that were randomized (but no intervention started) so they were not considered to be at-risk participants for adverse events.	5.3% 8/151 • Number of events 8 3 subjects that were randomized (but no intervention started) so they were not considered to be at-risk participants for adverse events.
Cardiac disorders Major Adverse Cardiac Events (MACE)	33.8% 51/151 • Number of events 51 3 subjects that were randomized (but no intervention started) so they were not considered to be at-risk participants for adverse events.	41.7% 63/151 • Number of events 63 3 subjects that were randomized (but no intervention started) so they were not considered to be at-risk participants for adverse events.

Other adverse events

Other adverse events
Measure	Intensive Insulin Treatment n=151 participants at risk Intensive insulin treatment (BG target: 100-140 mg/dL) Regular insulin (intensive treatment): Titration of the IV insulin rate for glucose goal 100-140 mg/dL	Conventional Insulin Treatment n=151 participants at risk Conventional insulin treatment (BG target: 141-180 mg/dl) Regular Insulin (conventional treatment): Titration of the IV insulin rate for glucose goal 141-180 mg/dl
Cardiac disorders Surgical re-intervention	4.6% 7/151 • Number of events 7 3 subjects that were randomized (but no intervention started) so they were not considered to be at-risk participants for adverse events.	6.0% 9/151 • Number of events 9 3 subjects that were randomized (but no intervention started) so they were not considered to be at-risk participants for adverse events.
Injury, poisoning and procedural complications ICU Re-admission	4.6% 7/151 • Number of events 7 3 subjects that were randomized (but no intervention started) so they were not considered to be at-risk participants for adverse events.	5.3% 8/151 • Number of events 8 3 subjects that were randomized (but no intervention started) so they were not considered to be at-risk participants for adverse events.
Endocrine disorders Hypoglycemia (ICU)	7.9% 12/151 • Number of events 12 3 subjects that were randomized (but no intervention started) so they were not considered to be at-risk participants for adverse events.	2.0% 3/151 • Number of events 3 3 subjects that were randomized (but no intervention started) so they were not considered to be at-risk participants for adverse events.
Endocrine disorders Hypoglycemia (immediately after treatment)	19.9% 30/151 • Number of events 30 3 subjects that were randomized (but no intervention started) so they were not considered to be at-risk participants for adverse events.	19.9% 30/151 • Number of events 30 3 subjects that were randomized (but no intervention started) so they were not considered to be at-risk participants for adverse events.

Additional Information

Dr. Guillermo Umpierrez

Emory University

Phone: 404-778-1665

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place