Trial Outcomes & Findings for The Association Between Peri-Operative Hyperglycemia and Major Morbidity and Mortality (NCT NCT00487162)

NCT ID: NCT00487162

Last Updated: 2016-11-08

Results Overview

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 56 participants
• Primary outcome timeframe: 7-10 days post op
• Results posted on: 2016-11-08

Participant Flow

enrollment period 6/07-3/09. potential subjects were recruited from the pre-operative admission unit and were screened if there ages were 18-90,undergoing general anesthesia for surgical procedures greater than 2 hours.

Subjects were randomized to a specific study arm based on a computer generated randomization table. 49 participants are included in the baseline characteristic module because although 56 signed consent, some subjects withdrew the consent prior to study procedures and several withdrawn by attending anesthesiologist.

Participant milestones

Measure	Conventional Glycemic Control Subjects randomized to this study arm had their glucose levels monitored hourly and if the result was greater than 200mg/dL their anesthesia care provider was notified. The subject was treated as to thie care provider discretion.	Intensive Glycemic Control In the intensive treatment group, continuous insulin infusion (50 IU of Novolin R \[Novo Nordisk\]) in 50ml of 0.9% saline via infusion pump will be started when the blood glucose level exceeds 110 mg / dL on two consecutive samples and will be adjusted to maintain the blood glucose level between 80 and 110 mg / dL. Adjustments will be made according to the University Hospital's ICU Adult Insulin Infusion Protocol - modified 10/1/07 (Appendix A). When the blood glucose level falls below 80 mg / dL, the insulin infusion will be tapered and discontinued. For patients going to the ICU after surgery, insulin infusions will be continued according to the University Hospital's ICU Adult Insulin Infusion Protocol under the direction of the ICU staff. For patients not being to the ICU after surgery, insulin infusions will be tapered to off after the final hourly blood glucose determination at three hours after the completion of surgery.
Overall Study STARTED	30	26
Overall Study COMPLETED	28	21
Overall Study NOT COMPLETED	2	5

Reasons for withdrawal

Measure	Conventional Glycemic Control Subjects randomized to this study arm had their glucose levels monitored hourly and if the result was greater than 200mg/dL their anesthesia care provider was notified. The subject was treated as to thie care provider discretion.	Intensive Glycemic Control In the intensive treatment group, continuous insulin infusion (50 IU of Novolin R \[Novo Nordisk\]) in 50ml of 0.9% saline via infusion pump will be started when the blood glucose level exceeds 110 mg / dL on two consecutive samples and will be adjusted to maintain the blood glucose level between 80 and 110 mg / dL. Adjustments will be made according to the University Hospital's ICU Adult Insulin Infusion Protocol - modified 10/1/07 (Appendix A). When the blood glucose level falls below 80 mg / dL, the insulin infusion will be tapered and discontinued. For patients going to the ICU after surgery, insulin infusions will be continued according to the University Hospital's ICU Adult Insulin Infusion Protocol under the direction of the ICU staff. For patients not being to the ICU after surgery, insulin infusions will be tapered to off after the final hourly blood glucose determination at three hours after the completion of surgery.
Overall Study Adverse Event	0	1
Overall Study Physician Decision	0	1
Overall Study Withdrawal by Subject	2	3

Baseline Characteristics

The Association Between Peri-Operative Hyperglycemia and Major Morbidity and Mortality

Baseline characteristics by cohort

Measure	Conventional Glycemic Control n=28 Participants Subjects randomized to this study arm had their glucose levels monitored hourly and if the result was greater than 200 mg/dL their anesthesia care provider was notified. The subject was treated as to their care provider discretion.	Intensive Glycemic Control n=21 Participants In this treatment group, continuous insulin infusion (50 IU of Novolin R \[Novo Nordisk\]) in 50mL of 0.9% saline via infusion pump will be started when the blood glucose level exceeds 110 mg/dL and will be adjusted to maintain the blood glucose level between 80 and 110 mg/dL.	Total n=49 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	25 Participants n=5 Participants	20 Participants n=7 Participants	45 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	13 Participants n=7 Participants	25 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	8 Participants n=7 Participants	24 Participants n=5 Participants

PRIMARY outcome

Timeframe: 7-10 days post op

Population: no analysis was done as the study was terminated due to patient safety concerns

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 0-48 hours post op

Population: no analysis was done as the study was terminated due to patient safety concerns

Outcome measures

Outcome data not reported

Adverse Events

Conventional Glycemic Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Intensive Glycemic Control

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Conventional Glycemic Control n=28 participants at risk Subjects randomized to this study arm had their glucose levels monitored hourly and if the result was greater than 200mg/dL their anesthesia care provider was notified. The subject was treated as to their care provider discretion.	Intensive Glycemic Control n=21 participants at risk Subjects randomized to this group had glucose levels monitored hourly and when \>110mg/dL an insulin drip was initiated to maintain glucose levels between 80-110
Endocrine disorders hypoglycemia	0.00% 0/28	4.8% 1/21

Additional Information

J. Jeffrey Freda, MD, MBA

UMDNJ-NJMS

Phone: 973 972-5007

Email: jjfreda@umdnj.edu

Results disclosure agreements

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