Trial Outcomes & Findings for Effect of Low-Dose Dexamethasone on the Incidence of Hyperglycemia Following Surgery (NCT NCT01545700)
NCT ID: NCT01545700
Last Updated: 2019-09-30
Results Overview
Serum blood glucose concentrations
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
200 participants
Primary outcome timeframe
Patient were followed for the duration of hospitalization, for an average of 6 days
Results posted on
2019-09-30
Participant Flow
This study was conducted at NorthShore University HealthSystem (a single tertiary medical center affiliated with the University of Chicago Pritzker School of Medicine) and was registered with ClinicalTrials.gov (NCT #01545700). Participants were recruited by reviewing operating room schedules and contact by telephone on the day before surgery.
A total of 200 patients were enrolled in this clinical trial.
Participant milestones
| Measure |
Control, Saline 0-4 Hours
2 cc of saline
Control-saline : Patients are randomized to receive saline 2 cc
|
Dexamethasone 4 mg, 0-4 Hours
Dexamethasone 4 mg administered intraoperatively
Dexamethasone 4 mg : Patients randomized to receive dexamethasone 4mg and 1 cc saline
|
Dexamethasone 8 mg, 0-4 Hours
Dexamethasone 8 mg administered intraoperatively
Dexamethasone 8 mg : Patients randomized to receive dexamethasone 8mg
|
Placebo Comparator Saline 8-24 Hours
placebo, 2 cc saline
Control saline : Patients are randomized to receive saline 2 cc
|
Dexamethasone 4 mg, 8-24 Hours
Dexamethasone 4 mg administered intraoperatively
Dexamethasone 4 mg : Patients are randomized to receive dexamethasone 4 mg and saline 1 cc
|
Dexamethasone 8 mg, 8-24 Hours
Dexamethasone 8 mg administered intraoperatively
Dexamethasone 8 mg : Patients are randomized to receive dexamethasone 8 mg
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
34
|
33
|
33
|
34
|
33
|
33
|
|
Overall Study
COMPLETED
|
33
|
32
|
31
|
34
|
32
|
33
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
2
|
0
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Low-Dose Dexamethasone on the Incidence of Hyperglycemia Following Surgery
Baseline characteristics by cohort
| Measure |
Control, Saline 0-4 Hours
n=34 Participants
2 cc of saline
Control-saline : Patients are randomized to receive saline 2 cc
|
Dexamethasone 4 mg, 0-4 Hours
n=33 Participants
Dexamethasone 4 mg administered intraoperatively
Dexamethasone 4 mg : Patients randomized to receive dexamethasone 4mg and 1 cc saline
|
Dexamethasone 8 mg, 0-4 Hours
n=33 Participants
Dexamethasone 8 mg administered intraoperatively
Dexamethasone 8 mg : Patients randomized to receive dexamethasone 8mg
|
Placebo Comparator Saline 8-24 Hours
n=34 Participants
placebo, 2 cc saline
Control saline : Patients are randomized to receive saline 2 cc
|
Dexamethasone 4 mg, 8-24 Hours
n=33 Participants
Dexamethasone 4 mg administered intraoperatively
Dexamethasone 4 mg : Patients are randomized to receive dexamethasone 4 mg and saline 1 cc
|
Dexamethasone 8 mg, 8-24 Hours
n=33 Participants
Dexamethasone 8 mg administered intraoperatively
Dexamethasone 8 mg : Patients are randomized to receive dexamethasone 8 mg
|
Total
n=200 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
29 Participants
n=93 Participants
|
29 Participants
n=4 Participants
|
30 Participants
n=27 Participants
|
25 Participants
n=483 Participants
|
28 Participants
n=36 Participants
|
28 Participants
n=10 Participants
|
169 Participants
n=115 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
9 Participants
n=483 Participants
|
5 Participants
n=36 Participants
|
5 Participants
n=10 Participants
|
31 Participants
n=115 Participants
|
|
Age, Continuous
|
53 years
STANDARD_DEVIATION 10 • n=93 Participants
|
53 years
STANDARD_DEVIATION 9 • n=4 Participants
|
53 years
STANDARD_DEVIATION 11 • n=27 Participants
|
57 years
STANDARD_DEVIATION 12 • n=483 Participants
|
53 years
STANDARD_DEVIATION 13 • n=36 Participants
|
56 years
STANDARD_DEVIATION 11 • n=10 Participants
|
54 years
STANDARD_DEVIATION 9 • n=115 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=93 Participants
|
33 Participants
n=4 Participants
|
33 Participants
n=27 Participants
|
34 Participants
n=483 Participants
|
33 Participants
n=36 Participants
|
33 Participants
n=10 Participants
|
200 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Region of Enrollment
United States
|
34 participants
n=93 Participants
|
33 participants
n=4 Participants
|
33 participants
n=27 Participants
|
34 participants
n=483 Participants
|
33 participants
n=36 Participants
|
33 participants
n=10 Participants
|
200 participants
n=115 Participants
|
PRIMARY outcome
Timeframe: Patient were followed for the duration of hospitalization, for an average of 6 daysPopulation: per protocol
Serum blood glucose concentrations
Outcome measures
| Measure |
Placebo 0-4 Hours
n=34 Participants
Placebo 0-4 hours baseline
|
Dexamethasone 4 mg 0-4 Hours
n=33 Participants
|
Dexamethasone 8 mg 0-4 Hours
n=33 Participants
|
Placebo 8-24 Hours
n=33 Participants
|
Dexamethasone 4 mg 8-24 Hours
n=33 Participants
|
Dexamethasone 8 mg 8-24 Hours
n=32 Participants
|
Dexamethasone 4 mg 0-4 Hours-1 Hour
n=32 Participants
|
Dexamethasone 4 mg 0-4 Hours-2 Hours
n=32 Participants
|
Dexamethasone 4 mg 0-4 Hours-3 Hours
n=32 Participants
|
Dexamethasone 4 mg 0-4 Hours-4 Hours
n=32 Participants
|
Dexamethasone 8 mg 0-4 Hours-baseline
n=31 Participants
|
Dexamethasone 8 mg 0-4 Hours-1 Hour
n=31 Participants
|
Dexamethasone 8 mg 0-4 Hours-2 Hours
n=31 Participants
|
Dexamethasone 8 mg 0-4 Hours-3 Hours
n=31 Participants
|
Dexamethasone 8 mg 0-4 Hours-4 Hours
n=31 Participants
|
Placebo 8-24 Hours Baseline
n=34 Participants
|
Placebo 8-24 Hours-8 Hours
n=34 Participants
|
Placebo 8-24 Hours-24 Hours
n=34 Participants
|
Dexamethasone 4 mg 8-24 Hours-baseline
n=32 Participants
|
Dexamethasone 4 mg 8-24 Hours-8 Hours
n=32 Participants
|
Dexamethasone 4 mg 8-24 Hours-24 Hours
n=32 Participants
|
Dexamethasone 8 mg 8-24 Hours-baseline
n=33 Participants
|
Dexamethasone 8 mg 8-24 Hours-8 Hours
n=33 Participants
|
Dexamethasone 8 mg 8-24 Hours-24 Hours
n=33 Participants
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Serum Blood Glucose Concentrations
|
101 mg/dl
Standard Deviation 15
|
137 mg/dl
Standard Deviation 29
|
140 mg/dl
Standard Deviation 28
|
141 mg/dl
Standard Deviation 34
|
139 mg/dl
Standard Deviation 34
|
107 mg/dl
Standard Deviation 21
|
141 mg/dl
Standard Deviation 23
|
159 mg/dl
Standard Deviation 33
|
159 mg/dl
Standard Deviation 30
|
159 mg/dl
Standard Deviation 25
|
108 mg/dl
Standard Deviation 23
|
138 mg/dl
Standard Deviation 27
|
151 mg/dl
Standard Deviation 23
|
146 mg/dl
Standard Deviation 22
|
149 mg/dl
Standard Deviation 25
|
101 mg/dl
Standard Deviation 19
|
150 mg/dl
Standard Deviation 36
|
121 mg/dl
Standard Deviation 26
|
98 mg/dl
Standard Deviation 16
|
149 mg/dl
Standard Deviation 28
|
119 mg/dl
Standard Deviation 16
|
100 mg/dl
Standard Deviation 19
|
151 mg/dl
Standard Deviation 36
|
124 mg/dl
Standard Deviation 27
|
SECONDARY outcome
Timeframe: Patients were followed for the duration of hospitalization, for an average of 6 daysVAS pain scoes at rest 0=no pain, 100=worst pain imaginable
Outcome measures
| Measure |
Placebo 0-4 Hours
n=33 Participants
Placebo 0-4 hours baseline
|
Dexamethasone 4 mg 0-4 Hours
n=32 Participants
|
Dexamethasone 8 mg 0-4 Hours
n=31 Participants
|
Placebo 8-24 Hours
n=34 Participants
|
Dexamethasone 4 mg 8-24 Hours
n=32 Participants
|
Dexamethasone 8 mg 8-24 Hours
n=33 Participants
|
Dexamethasone 4 mg 0-4 Hours-1 Hour
|
Dexamethasone 4 mg 0-4 Hours-2 Hours
|
Dexamethasone 4 mg 0-4 Hours-3 Hours
|
Dexamethasone 4 mg 0-4 Hours-4 Hours
|
Dexamethasone 8 mg 0-4 Hours-baseline
|
Dexamethasone 8 mg 0-4 Hours-1 Hour
|
Dexamethasone 8 mg 0-4 Hours-2 Hours
|
Dexamethasone 8 mg 0-4 Hours-3 Hours
|
Dexamethasone 8 mg 0-4 Hours-4 Hours
|
Placebo 8-24 Hours Baseline
|
Placebo 8-24 Hours-8 Hours
|
Placebo 8-24 Hours-24 Hours
|
Dexamethasone 4 mg 8-24 Hours-baseline
|
Dexamethasone 4 mg 8-24 Hours-8 Hours
|
Dexamethasone 4 mg 8-24 Hours-24 Hours
|
Dexamethasone 8 mg 8-24 Hours-baseline
|
Dexamethasone 8 mg 8-24 Hours-8 Hours
|
Dexamethasone 8 mg 8-24 Hours-24 Hours
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Pain Scores
|
50 0-100 VAS scale scores on a scale
Standard Deviation 21
|
47 0-100 VAS scale scores on a scale
Standard Deviation 26
|
45 0-100 VAS scale scores on a scale
Standard Deviation 24
|
50 0-100 VAS scale scores on a scale
Standard Deviation 21
|
45 0-100 VAS scale scores on a scale
Standard Deviation 17
|
44.5 0-100 VAS scale scores on a scale
Standard Deviation 23
|
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Adverse Events
Control-saline Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Dexamethasone Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place