Trial Outcomes & Findings for Glycemic Control to Prevent Cardiac Morbidity in Vascular Surgery (NCT NCT00328094)

NCT ID: NCT00328094

Last Updated: 2013-04-17

Results Overview

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 242 participants
• Primary outcome timeframe: hospital length of stay
• Results posted on: 2013-04-17

Participant Flow

Perioperative period in Beth Israel Deaconess Medical Center, West Campus was the only location for the recruitment.

252 were assessed for eligibility. 10 did not meet inclusion criterion.

Participant milestones

Measure	Continuous Insulin Infusion Tight glucose group with insulin infusion	Intermittent Insulin Bolus Intermittent insulin boluses group
Overall Study STARTED	117	125
Overall Study COMPLETED	114	122
Overall Study NOT COMPLETED	3	3

Reasons for withdrawal

Measure	Continuous Insulin Infusion Tight glucose group with insulin infusion	Intermittent Insulin Bolus Intermittent insulin boluses group
Overall Study Physician Decision	3	3

Baseline Characteristics

Glycemic Control to Prevent Cardiac Morbidity in Vascular Surgery

Baseline characteristics by cohort

Measure	Continuous Insulin Infusion n=114 Participants Tight glucose group with insulin infusion	Intermittent Insulin Bolus n=122 Participants Intermittent insulin boluses group	Total n=236 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	49 Participants n=5 Participants	43 Participants n=7 Participants	92 Participants n=5 Participants
Age, Categorical >=65 years	65 Participants n=5 Participants	79 Participants n=7 Participants	144 Participants n=5 Participants
Age Continuous	67 years STANDARD_DEVIATION 10 • n=5 Participants	71 years STANDARD_DEVIATION 11 • n=7 Participants	69 years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	47 Participants n=5 Participants	56 Participants n=7 Participants	103 Participants n=5 Participants
Sex: Female, Male Male	67 Participants n=5 Participants	66 Participants n=7 Participants	133 Participants n=5 Participants
Region of Enrollment United States	114 participants n=5 Participants	122 participants n=7 Participants	236 participants n=5 Participants

PRIMARY outcome

Timeframe: hospital length of stay

Outcome measures

Measure	Continuous Insulin Infusion n=114 Participants Tight glucose group with insulin infusion	Intermittent Insulin Bolus n=122 Participants Intermittent insulin boluses group
Composite (Myocardial Infarction and CHF)	4 Number of patients	15 Number of patients

SECONDARY outcome

Timeframe: postoperative

Outcome measures

Measure	Continuous Insulin Infusion n=114 Participants Tight glucose group with insulin infusion	Intermittent Insulin Bolus n=122 Participants Intermittent insulin boluses group
Incidence of Wound Infections	35 participants	29 participants

Adverse Events

Continuous Insulin Infusion

Serious events: 10 serious events

Other events: 23 other events

Deaths: 0 deaths

Intermittent Insulin Bolus

Serious events: 5 serious events

Other events: 22 other events

Deaths: 0 deaths

Serious adverse events

Measure	Continuous Insulin Infusion n=114 participants at risk Tight glucose group with insulin infusion	Intermittent Insulin Bolus n=122 participants at risk Intermittent insulin boluses group
Metabolism and nutrition disorders HYPOGLYCEMIA	8.8% 10/114 • Number of events 10 • Study period. Hospital stay	4.1% 5/122 • Number of events 5 • Study period. Hospital stay

Other adverse events

Measure	Continuous Insulin Infusion n=114 participants at risk Tight glucose group with insulin infusion	Intermittent Insulin Bolus n=122 participants at risk Intermittent insulin boluses group
Renal and urinary disorders Creatinine > 25% increase	20.2% 23/114 • Number of events 23 • Study period. Hospital stay	18.0% 22/122 • Number of events 22 • Study period. Hospital stay

Additional Information

Dr. Balachundhar Subramaniam, MD MPH

Beth Israel Deaconess Medical Center, Boston, MA

Phone: 6177542675

Email: bsubrama@bidmc.harvard.edu

Results disclosure agreements

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