Trial Outcomes & Findings for The Effects of Corticosteroids, Glucose Control, and Depth-of-Anesthesia on Perioperative Inflammation and Morbidity From Major Non-cardiac Surgery (Dexamethasone, Light Anesthesia and Tight Glucose Control (DeLiT Trial)) (NCT NCT00995501)
NCT ID: NCT00995501
Last Updated: 2017-04-25
Results Overview
Our primary outcome was a collapsed composite endpoint (any versus none) defined as the occurrence of at least one of sixteen major complications before hospital discharge, including sepsis, severe surgical site infection, myocardial infarction, heart failure, stroke, unstable ventricular arrhythmias, pulmonary embolism, pneumonia, respiratory failure, dialysis dependent renal failure, large pleural or peritoneal effusions, major bleeding, major wound and surgical site healing complications, vascular graft thrombosis, and 30-day mortality.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
381 participants
Primary outcome timeframe
30 day after surgery
Results posted on
2017-04-25
Participant Flow
Participant milestones
| Measure |
Intensive Glucose Control, Dexamethasone, Light Anesthesia
* Intensive Glucose Control The target range for blood glucose will be 80-110 mg/dl
* Dexamethasone Dexamethasone administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.
* Light anesthesia target BIS of 55
Dexamethasone Sodium Sulfate: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning
Insulin: Insulin to maintain blood glucose 80-110 mg/dl.
anesthesia management: Light anesthesia to maintain BIS about 55
|
Intensive Glucose Control, Dexamethasone, Deep Anesthesia
* Intensive Glucose Control The target range for blood glucose will be 80-110 mg/dl
* Dexamethasone Dexamethasone administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.
* Deep anesthesia target BIS of 35
Dexamethasone Sodium Sulfate: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning
Insulin: Insulin to maintain blood glucose 80-110 mg/dl.
Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35
|
Intensive Glucose Control, Placebo, Light Anesthesia
* Intensive Glucose Control The target range for blood glucose will be 80-110 mg/dl
* Placebo Placebo administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.
* Light anesthesia target BIS of 55
Dexamethasone Sodium Sulfate: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning
anesthesia management: Light anesthesia to maintain BIS about 55
Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl.
|
Conventional Glucose Control, Dexamethasone, Light Anesthesia
* Conventional Glucose Control The target range for blood glucose will be 180-200 mg/dl
* Dexamethasone Dexamethasone administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.
* Light anesthesia target BIS of 55
Insulin: Insulin to maintain blood glucose 80-110 mg/dl.
anesthesia management: Light anesthesia to maintain BIS about 55
Dexamethasone - placebo: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning
|
Intensive Glucose Control, Placebo, Deep Anesthesia
* Intensive Glucose Control The target range for blood glucose will be 80-110 mg/dl
* Placebo Placebo administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.
* Deep anesthesia target BIS of 35
Dexamethasone Sodium Sulfate: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning
Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl.
Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35
|
Conventional Glucose Control, Dexamethasone, Deep Anesthesia
* Conventional Glucose Control The target range for blood glucose will be 180-200 mg/dl
* Dexamethasone Dexamethasone administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.
* Deep anesthesia target BIS of 35
Insulin: Insulin to maintain blood glucose 80-110 mg/dl.
Dexamethasone - placebo: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning
Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35
|
Conventional Glucose Control, Placebo, Light Anesthesia
* Conventional Glucose Control The target range for blood glucose will be 180-200 mg/dl
* Placebo Placebo administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.
* Light anesthesia target BIS of 55
anesthesia management: Light anesthesia to maintain BIS about 55
Dexamethasone - placebo: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning
Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl.
|
Conventional Glucose Control, Placebo, Deep Anesthesia
* Conventional Glucose Control The target range for blood glucose will be 180-200 mg/dl
* Placebo Placebo administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.
* Deep anesthesia target BIS of 35
Dexamethasone - placebo: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning
Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl.
Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
52
|
51
|
47
|
46
|
46
|
44
|
49
|
46
|
|
Overall Study
COMPLETED
|
52
|
51
|
47
|
46
|
46
|
44
|
49
|
46
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Effects of Corticosteroids, Glucose Control, and Depth-of-Anesthesia on Perioperative Inflammation and Morbidity From Major Non-cardiac Surgery (Dexamethasone, Light Anesthesia and Tight Glucose Control (DeLiT Trial))
Baseline characteristics by cohort
| Measure |
Intensive Glucose Control, Dexamethasone, Light Anesthesia
n=52 Participants
* Intensive Glucose Control The target range for blood glucose will be 80-110 mg/dl
* Dexamethasone Dexamethasone administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.
* Light anesthesia target BIS of 55
Dexamethasone Sodium Sulfate: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning
Insulin: Insulin to maintain blood glucose 80-110 mg/dl.
anesthesia management: Light anesthesia to maintain BIS about 55
|
Intensive Glucose Control, Dexamethasone, Deep Anesthesia
n=51 Participants
* Intensive Glucose Control The target range for blood glucose will be 80-110 mg/dl
* Dexamethasone Dexamethasone administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.
* Deep anesthesia target BIS of 35
Dexamethasone Sodium Sulfate: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning
Insulin: Insulin to maintain blood glucose 80-110 mg/dl.
Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35
|
Intensive Glucose Control, Placebo, Light Anesthesia
n=47 Participants
* Intensive Glucose Control The target range for blood glucose will be 80-110 mg/dl
* Placebo Placebo administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.
* Light anesthesia target BIS of 55
Dexamethasone Sodium Sulfate: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning
anesthesia management: Light anesthesia to maintain BIS about 55
Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl.
|
Conventional Glucose Control, Dexamethasone, Light Anesthesia
n=46 Participants
* Conventional Glucose Control The target range for blood glucose will be 180-200 mg/dl
* Dexamethasone Dexamethasone administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.
* Light anesthesia target BIS of 55
Insulin: Insulin to maintain blood glucose 80-110 mg/dl.
anesthesia management: Light anesthesia to maintain BIS about 55
Dexamethasone - placebo: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning
|
Intensive Glucose Control, Placebo, Deep Anesthesia
n=46 Participants
* Intensive Glucose Control The target range for blood glucose will be 80-110 mg/dl
* Placebo Placebo administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.
* Deep anesthesia target BIS of 35
Dexamethasone Sodium Sulfate: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning
Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl.
Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35
|
Conventional Glucose Control, Dexamethasone, Deep Anesthesia
n=44 Participants
* Conventional Glucose Control The target range for blood glucose will be 180-200 mg/dl
* Dexamethasone Dexamethasone administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.
* Deep anesthesia target BIS of 35
Insulin: Insulin to maintain blood glucose 80-110 mg/dl.
Dexamethasone - placebo: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning
Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35
|
Conventional Glucose Control, Placebo, Light Anesthesia
n=49 Participants
* Conventional Glucose Control The target range for blood glucose will be 180-200 mg/dl
* Placebo Placebo administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.
* Light anesthesia target BIS of 55
anesthesia management: Light anesthesia to maintain BIS about 55
Dexamethasone - placebo: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning
Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl.
|
Conventional Glucose Control, Placebo, Deep Anesthesia
n=46 Participants
* Conventional Glucose Control The target range for blood glucose will be 180-200 mg/dl
* Placebo Placebo administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.
* Deep anesthesia target BIS of 35
Dexamethasone - placebo: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning
Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl.
Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35
|
Total
n=381 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
63 years
STANDARD_DEVIATION 10 • n=5 Participants
|
65 years
STANDARD_DEVIATION 11 • n=7 Participants
|
64 years
STANDARD_DEVIATION 11 • n=5 Participants
|
64 years
STANDARD_DEVIATION 11 • n=4 Participants
|
65 years
STANDARD_DEVIATION 13 • n=21 Participants
|
64 years
STANDARD_DEVIATION 11 • n=8 Participants
|
63 years
STANDARD_DEVIATION 12 • n=8 Participants
|
65 years
STANDARD_DEVIATION 12 • n=24 Participants
|
64 years
STANDARD_DEVIATION 11 • n=42 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
13 Participants
n=8 Participants
|
17 Participants
n=8 Participants
|
13 Participants
n=24 Participants
|
127 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
31 Participants
n=8 Participants
|
32 Participants
n=8 Participants
|
33 Participants
n=24 Participants
|
254 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
White
|
49 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
44 Participants
n=21 Participants
|
43 Participants
n=8 Participants
|
48 Participants
n=8 Participants
|
42 Participants
n=24 Participants
|
362 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
African American
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
18 Participants
n=42 Participants
|
|
Body mass index
|
28 kg/m^2
STANDARD_DEVIATION 4 • n=5 Participants
|
30 kg/m^2
STANDARD_DEVIATION 6 • n=7 Participants
|
28 kg/m^2
STANDARD_DEVIATION 6 • n=5 Participants
|
28 kg/m^2
STANDARD_DEVIATION 8 • n=4 Participants
|
28 kg/m^2
STANDARD_DEVIATION 6 • n=21 Participants
|
27 kg/m^2
STANDARD_DEVIATION 5 • n=8 Participants
|
27 kg/m^2
STANDARD_DEVIATION 6 • n=8 Participants
|
29 kg/m^2
STANDARD_DEVIATION 6 • n=24 Participants
|
28 kg/m^2
STANDARD_DEVIATION 6 • n=42 Participants
|
PRIMARY outcome
Timeframe: 30 day after surgeryOur primary outcome was a collapsed composite endpoint (any versus none) defined as the occurrence of at least one of sixteen major complications before hospital discharge, including sepsis, severe surgical site infection, myocardial infarction, heart failure, stroke, unstable ventricular arrhythmias, pulmonary embolism, pneumonia, respiratory failure, dialysis dependent renal failure, large pleural or peritoneal effusions, major bleeding, major wound and surgical site healing complications, vascular graft thrombosis, and 30-day mortality.
Outcome measures
| Measure |
Intensive Glucose Control, Dexamethasone, Light Anesthesia
n=52 Participants
* Intensive Glucose Control The target range for blood glucose will be 80-110 mg/dl
* Dexamethasone Dexamethasone administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.
* Light anesthesia target BIS of 55
Dexamethasone Sodium Sulfate: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning
Insulin: Insulin to maintain blood glucose 80-110 mg/dl.
anesthesia management: Light anesthesia to maintain BIS about 55
|
Intensive Glucose Control, Dexamethasone, Deep Anesthesia
n=51 Participants
* Intensive Glucose Control The target range for blood glucose will be 80-110 mg/dl
* Dexamethasone Dexamethasone administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.
* Deep anesthesia target BIS of 35
Dexamethasone Sodium Sulfate: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning
Insulin: Insulin to maintain blood glucose 80-110 mg/dl.
Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35
|
Intensive Glucose Control, Placebo, Light Anesthesia
n=47 Participants
* Intensive Glucose Control The target range for blood glucose will be 80-110 mg/dl
* Placebo Placebo administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.
* Light anesthesia target BIS of 55
Dexamethasone Sodium Sulfate: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning
anesthesia management: Light anesthesia to maintain BIS about 55
Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl.
|
Conventional Glucose Control, Dexamethasone, Light Anesthesia
n=46 Participants
* Conventional Glucose Control The target range for blood glucose will be 180-200 mg/dl
* Dexamethasone Dexamethasone administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.
* Light anesthesia target BIS of 55
Insulin: Insulin to maintain blood glucose 80-110 mg/dl.
anesthesia management: Light anesthesia to maintain BIS about 55
Dexamethasone - placebo: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning
|
Intensive Glucose Control, Placebo, Deep Anesthesia
n=46 Participants
* Intensive Glucose Control The target range for blood glucose will be 80-110 mg/dl
* Placebo Placebo administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.
* Deep anesthesia target BIS of 35
Dexamethasone Sodium Sulfate: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning
Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl.
Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35
|
Conventional Glucose Control, Dexamethasone, Deep Anesthesia
n=44 Participants
* Conventional Glucose Control The target range for blood glucose will be 180-200 mg/dl
* Dexamethasone Dexamethasone administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.
* Deep anesthesia target BIS of 35
Insulin: Insulin to maintain blood glucose 80-110 mg/dl.
Dexamethasone - placebo: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning
Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35
|
Conventional Glucose Control, Placebo, Light Anesthesia
n=49 Participants
* Conventional Glucose Control The target range for blood glucose will be 180-200 mg/dl
* Placebo Placebo administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.
* Light anesthesia target BIS of 55
anesthesia management: Light anesthesia to maintain BIS about 55
Dexamethasone - placebo: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning
Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl.
|
Conventional Glucose Control, Placebo, Deep Anesthesia
n=46 Participants
* Conventional Glucose Control The target range for blood glucose will be 180-200 mg/dl
* Placebo Placebo administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.
* Deep anesthesia target BIS of 35
Dexamethasone - placebo: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning
Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl.
Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35
|
|---|---|---|---|---|---|---|---|---|
|
Major Perioperative Morbidity
|
10 Participants
|
10 Participants
|
8 Participants
|
9 Participants
|
10 Participants
|
8 Participants
|
11 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 1 year after surgeryAll-cause mortality
Outcome measures
| Measure |
Intensive Glucose Control, Dexamethasone, Light Anesthesia
n=52 Participants
* Intensive Glucose Control The target range for blood glucose will be 80-110 mg/dl
* Dexamethasone Dexamethasone administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.
* Light anesthesia target BIS of 55
Dexamethasone Sodium Sulfate: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning
Insulin: Insulin to maintain blood glucose 80-110 mg/dl.
anesthesia management: Light anesthesia to maintain BIS about 55
|
Intensive Glucose Control, Dexamethasone, Deep Anesthesia
n=51 Participants
* Intensive Glucose Control The target range for blood glucose will be 80-110 mg/dl
* Dexamethasone Dexamethasone administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.
* Deep anesthesia target BIS of 35
Dexamethasone Sodium Sulfate: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning
Insulin: Insulin to maintain blood glucose 80-110 mg/dl.
Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35
|
Intensive Glucose Control, Placebo, Light Anesthesia
n=47 Participants
* Intensive Glucose Control The target range for blood glucose will be 80-110 mg/dl
* Placebo Placebo administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.
* Light anesthesia target BIS of 55
Dexamethasone Sodium Sulfate: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning
anesthesia management: Light anesthesia to maintain BIS about 55
Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl.
|
Conventional Glucose Control, Dexamethasone, Light Anesthesia
n=46 Participants
* Conventional Glucose Control The target range for blood glucose will be 180-200 mg/dl
* Dexamethasone Dexamethasone administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.
* Light anesthesia target BIS of 55
Insulin: Insulin to maintain blood glucose 80-110 mg/dl.
anesthesia management: Light anesthesia to maintain BIS about 55
Dexamethasone - placebo: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning
|
Intensive Glucose Control, Placebo, Deep Anesthesia
n=46 Participants
* Intensive Glucose Control The target range for blood glucose will be 80-110 mg/dl
* Placebo Placebo administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.
* Deep anesthesia target BIS of 35
Dexamethasone Sodium Sulfate: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning
Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl.
Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35
|
Conventional Glucose Control, Dexamethasone, Deep Anesthesia
n=44 Participants
* Conventional Glucose Control The target range for blood glucose will be 180-200 mg/dl
* Dexamethasone Dexamethasone administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.
* Deep anesthesia target BIS of 35
Insulin: Insulin to maintain blood glucose 80-110 mg/dl.
Dexamethasone - placebo: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning
Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35
|
Conventional Glucose Control, Placebo, Light Anesthesia
n=49 Participants
* Conventional Glucose Control The target range for blood glucose will be 180-200 mg/dl
* Placebo Placebo administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.
* Light anesthesia target BIS of 55
anesthesia management: Light anesthesia to maintain BIS about 55
Dexamethasone - placebo: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning
Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl.
|
Conventional Glucose Control, Placebo, Deep Anesthesia
n=46 Participants
* Conventional Glucose Control The target range for blood glucose will be 180-200 mg/dl
* Placebo Placebo administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.
* Deep anesthesia target BIS of 35
Dexamethasone - placebo: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning
Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl.
Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35
|
|---|---|---|---|---|---|---|---|---|
|
1 Year Mortality
|
1 Participants
|
7 Participants
|
9 Participants
|
7 Participants
|
7 Participants
|
7 Participants
|
5 Participants
|
2 Participants
|
Adverse Events
Intensive Glucose Control, Dexamethasone, Light Anesthesia
Serious events: 10 serious events
Other events: 15 other events
Deaths: 1 deaths
Intensive Glucose Control, Dexamethasone, Deep Anesthesia
Serious events: 10 serious events
Other events: 25 other events
Deaths: 7 deaths
Intensive Glucose Control, Placebo, Light Anesthesia
Serious events: 8 serious events
Other events: 20 other events
Deaths: 9 deaths
Conventional Glucose Control, Dexamethasone, Light Anesthesia
Serious events: 9 serious events
Other events: 17 other events
Deaths: 7 deaths
Intensive Glucose Control, Placebo, Deep Anesthesia
Serious events: 10 serious events
Other events: 22 other events
Deaths: 7 deaths
Conventional Glucose Control, Dexamethasone, Deep Anesthesia
Serious events: 8 serious events
Other events: 21 other events
Deaths: 7 deaths
Conventional Glucose Control, Placebo, Light Anesthesia
Serious events: 11 serious events
Other events: 20 other events
Deaths: 5 deaths
Conventional Glucose Control, Placebo, Deep Anesthesia
Serious events: 9 serious events
Other events: 24 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Intensive Glucose Control, Dexamethasone, Light Anesthesia
n=52 participants at risk
* Intensive Glucose Control The target range for blood glucose will be 80-110 mg/dl
* Dexamethasone Dexamethasone administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.
* Light anesthesia target BIS of 55
Dexamethasone Sodium Sulfate: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning
Insulin: Insulin to maintain blood glucose 80-110 mg/dl.
anesthesia management: Light anesthesia to maintain BIS about 55
|
Intensive Glucose Control, Dexamethasone, Deep Anesthesia
n=51 participants at risk
* Intensive Glucose Control The target range for blood glucose will be 80-110 mg/dl
* Dexamethasone Dexamethasone administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.
* Deep anesthesia target BIS of 35
Dexamethasone Sodium Sulfate: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning
Insulin: Insulin to maintain blood glucose 80-110 mg/dl.
Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35
|
Intensive Glucose Control, Placebo, Light Anesthesia
n=47 participants at risk
* Intensive Glucose Control The target range for blood glucose will be 80-110 mg/dl
* Placebo Placebo administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.
* Light anesthesia target BIS of 55
Dexamethasone Sodium Sulfate: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning
anesthesia management: Light anesthesia to maintain BIS about 55
Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl.
|
Conventional Glucose Control, Dexamethasone, Light Anesthesia
n=46 participants at risk
* Conventional Glucose Control The target range for blood glucose will be 180-200 mg/dl
* Dexamethasone Dexamethasone administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.
* Light anesthesia target BIS of 55
Insulin: Insulin to maintain blood glucose 80-110 mg/dl.
anesthesia management: Light anesthesia to maintain BIS about 55
Dexamethasone - placebo: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning
|
Intensive Glucose Control, Placebo, Deep Anesthesia
n=46 participants at risk
* Intensive Glucose Control The target range for blood glucose will be 80-110 mg/dl
* Placebo Placebo administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.
* Deep anesthesia target BIS of 35
Dexamethasone Sodium Sulfate: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning
Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl.
Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35
|
Conventional Glucose Control, Dexamethasone, Deep Anesthesia
n=44 participants at risk
* Conventional Glucose Control The target range for blood glucose will be 180-200 mg/dl
* Dexamethasone Dexamethasone administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.
* Deep anesthesia target BIS of 35
Insulin: Insulin to maintain blood glucose 80-110 mg/dl.
Dexamethasone - placebo: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning
Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35
|
Conventional Glucose Control, Placebo, Light Anesthesia
n=49 participants at risk
* Conventional Glucose Control The target range for blood glucose will be 180-200 mg/dl
* Placebo Placebo administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.
* Light anesthesia target BIS of 55
anesthesia management: Light anesthesia to maintain BIS about 55
Dexamethasone - placebo: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning
Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl.
|
Conventional Glucose Control, Placebo, Deep Anesthesia
n=46 participants at risk
* Conventional Glucose Control The target range for blood glucose will be 180-200 mg/dl
* Placebo Placebo administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.
* Deep anesthesia target BIS of 35
Dexamethasone - placebo: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning
Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl.
Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35
|
|---|---|---|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
30-day major surgical complications
|
19.2%
10/52 • Number of events 10 • 1 year for all-cause mortality 30-day for major complications
|
19.6%
10/51 • Number of events 10 • 1 year for all-cause mortality 30-day for major complications
|
17.0%
8/47 • Number of events 8 • 1 year for all-cause mortality 30-day for major complications
|
19.6%
9/46 • Number of events 9 • 1 year for all-cause mortality 30-day for major complications
|
21.7%
10/46 • Number of events 10 • 1 year for all-cause mortality 30-day for major complications
|
18.2%
8/44 • Number of events 8 • 1 year for all-cause mortality 30-day for major complications
|
22.4%
11/49 • Number of events 11 • 1 year for all-cause mortality 30-day for major complications
|
19.6%
9/46 • Number of events 9 • 1 year for all-cause mortality 30-day for major complications
|
Other adverse events
| Measure |
Intensive Glucose Control, Dexamethasone, Light Anesthesia
n=52 participants at risk
* Intensive Glucose Control The target range for blood glucose will be 80-110 mg/dl
* Dexamethasone Dexamethasone administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.
* Light anesthesia target BIS of 55
Dexamethasone Sodium Sulfate: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning
Insulin: Insulin to maintain blood glucose 80-110 mg/dl.
anesthesia management: Light anesthesia to maintain BIS about 55
|
Intensive Glucose Control, Dexamethasone, Deep Anesthesia
n=51 participants at risk
* Intensive Glucose Control The target range for blood glucose will be 80-110 mg/dl
* Dexamethasone Dexamethasone administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.
* Deep anesthesia target BIS of 35
Dexamethasone Sodium Sulfate: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning
Insulin: Insulin to maintain blood glucose 80-110 mg/dl.
Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35
|
Intensive Glucose Control, Placebo, Light Anesthesia
n=47 participants at risk
* Intensive Glucose Control The target range for blood glucose will be 80-110 mg/dl
* Placebo Placebo administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.
* Light anesthesia target BIS of 55
Dexamethasone Sodium Sulfate: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning
anesthesia management: Light anesthesia to maintain BIS about 55
Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl.
|
Conventional Glucose Control, Dexamethasone, Light Anesthesia
n=46 participants at risk
* Conventional Glucose Control The target range for blood glucose will be 180-200 mg/dl
* Dexamethasone Dexamethasone administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.
* Light anesthesia target BIS of 55
Insulin: Insulin to maintain blood glucose 80-110 mg/dl.
anesthesia management: Light anesthesia to maintain BIS about 55
Dexamethasone - placebo: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning
|
Intensive Glucose Control, Placebo, Deep Anesthesia
n=46 participants at risk
* Intensive Glucose Control The target range for blood glucose will be 80-110 mg/dl
* Placebo Placebo administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.
* Deep anesthesia target BIS of 35
Dexamethasone Sodium Sulfate: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning
Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl.
Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35
|
Conventional Glucose Control, Dexamethasone, Deep Anesthesia
n=44 participants at risk
* Conventional Glucose Control The target range for blood glucose will be 180-200 mg/dl
* Dexamethasone Dexamethasone administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.
* Deep anesthesia target BIS of 35
Insulin: Insulin to maintain blood glucose 80-110 mg/dl.
Dexamethasone - placebo: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning
Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35
|
Conventional Glucose Control, Placebo, Light Anesthesia
n=49 participants at risk
* Conventional Glucose Control The target range for blood glucose will be 180-200 mg/dl
* Placebo Placebo administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.
* Light anesthesia target BIS of 55
anesthesia management: Light anesthesia to maintain BIS about 55
Dexamethasone - placebo: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning
Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl.
|
Conventional Glucose Control, Placebo, Deep Anesthesia
n=46 participants at risk
* Conventional Glucose Control The target range for blood glucose will be 180-200 mg/dl
* Placebo Placebo administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.
* Deep anesthesia target BIS of 35
Dexamethasone - placebo: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning
Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl.
Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35
|
|---|---|---|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
30-day minor surgical complications
|
28.8%
15/52 • Number of events 15 • 1 year for all-cause mortality 30-day for major complications
|
49.0%
25/51 • Number of events 25 • 1 year for all-cause mortality 30-day for major complications
|
42.6%
20/47 • Number of events 20 • 1 year for all-cause mortality 30-day for major complications
|
37.0%
17/46 • Number of events 17 • 1 year for all-cause mortality 30-day for major complications
|
47.8%
22/46 • Number of events 22 • 1 year for all-cause mortality 30-day for major complications
|
47.7%
21/44 • Number of events 21 • 1 year for all-cause mortality 30-day for major complications
|
40.8%
20/49 • Number of events 20 • 1 year for all-cause mortality 30-day for major complications
|
52.2%
24/46 • Number of events 24 • 1 year for all-cause mortality 30-day for major complications
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place