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Effect of Low-Dose Dexamethasone on the Incidence of Hyperglycemia Following Surgery

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ClinicalTrials.gov Identifier: NCT01545700
Recruitment Status : Completed
First Posted : March 7, 2012
Results First Posted : January 15, 2013
Last Update Posted : January 18, 2013
Sponsor:
Information provided by (Responsible Party):
Glenn S. Murphy, MD, NorthShore University HealthSystem Research Institute

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Postoperative Complications
Interventions Drug: Control-saline
Drug: Dexamethasone 4 mg
Drug: Dexamethasone 8 mg
Drug: Control saline
Enrollment 200
Recruitment Details 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.
Pre-assignment Details A total of 200 patients were enrolled in this clinical trial.
Arm/Group Title Control, Saline 0-4 Hours Dexamethasone 4 mg, 0-4 Hours Dexamethasone 8 mg, 0-4 Hours Placebo Comparator Saline 8-24 Hours Dexamethasone 4 mg, 8-24 Hours Dexamethasone 8 mg, 8-24 Hours
Hide Arm/Group Description

2 cc of saline

Control-saline : Patients are randomized to receive saline 2 cc

Dexamethasone 4 mg administered intraoperatively

Dexamethasone 4 mg : Patients randomized to receive dexamethasone 4mg and 1 cc saline

Dexamethasone 8 mg administered intraoperatively

Dexamethasone 8 mg : Patients randomized to receive dexamethasone 8mg

placebo, 2 cc saline

Control saline : Patients are randomized to receive saline 2 cc

Dexamethasone 4 mg administered intraoperatively

Dexamethasone 4 mg : Patients are randomized to receive dexamethasone 4 mg and saline 1 cc

Dexamethasone 8 mg administered intraoperatively

Dexamethasone 8 mg : Patients are randomized to receive dexamethasone 8 mg

Period Title: Overall Study
Started 34 33 33 34 33 33
Completed 33 32 31 34 32 33
Not Completed 1 1 2 0 1 0
Arm/Group Title Control, Saline 0-4 Hours Dexamethasone 4 mg, 0-4 Hours Dexamethasone 8 mg, 0-4 Hours Placebo Comparator Saline 8-24 Hours Dexamethasone 4 mg, 8-24 Hours Dexamethasone 8 mg, 8-24 Hours Total
Hide Arm/Group Description

2 cc of saline

Control-saline : Patients are randomized to receive saline 2 cc

Dexamethasone 4 mg administered intraoperatively

Dexamethasone 4 mg : Patients randomized to receive dexamethasone 4mg and 1 cc saline

Dexamethasone 8 mg administered intraoperatively

Dexamethasone 8 mg : Patients randomized to receive dexamethasone 8mg

placebo, 2 cc saline

Control saline : Patients are randomized to receive saline 2 cc

Dexamethasone 4 mg administered intraoperatively

Dexamethasone 4 mg : Patients are randomized to receive dexamethasone 4 mg and saline 1 cc

Dexamethasone 8 mg administered intraoperatively

Dexamethasone 8 mg : Patients are randomized to receive dexamethasone 8 mg

Total of all reporting groups
Overall Number of Baseline Participants 34 33 33 34 33 33 200
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 33 participants 33 participants 34 participants 33 participants 33 participants 200 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
29
  85.3%
29
  87.9%
30
  90.9%
25
  73.5%
28
  84.8%
28
  84.8%
169
  84.5%
>=65 years
5
  14.7%
4
  12.1%
3
   9.1%
9
  26.5%
5
  15.2%
5
  15.2%
31
  15.5%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 34 participants 33 participants 33 participants 34 participants 33 participants 33 participants 200 participants
53  (10) 53  (9) 53  (11) 57  (12) 53  (13) 56  (11) 54  (9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 33 participants 33 participants 34 participants 33 participants 33 participants 200 participants
Female
34
 100.0%
33
 100.0%
33
 100.0%
34
 100.0%
33
 100.0%
33
 100.0%
200
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 34 participants 33 participants 33 participants 34 participants 33 participants 33 participants 200 participants
34 33 33 34 33 33 200
1.Primary Outcome
Title Serum Blood Glucose Concentrations
Hide Description Serum blood glucose concentrations
Time Frame Patient were followed for the duration of hospitalization, for an average of 6 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
per protocol
Arm/Group Title Placebo 0-4 Hours-baseline Placebo 0-4 Hours-1 Hour Placebo 0-4 Hours-2 Hours Placebo 0-4 Hours-3 Hours Placebo 0-4 Hours-4 Hours Dexamethasone 4 mg 0-4 Hours-baseline 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
Hide Arm/Group Description:
Placebo 0-4 hours baseline
Placebo 0-4 hours-1 hour
Placebo 0-4 hours-2 hours
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
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[Not Specified]
Overall Number of Participants Analyzed 34 33 33 33 33 32 32 32 32 32 31 31 31 31 31 34 34 34 32 32 32 33 33 33
Mean (Standard Deviation)
Unit of Measure: mg/dl
101  (15) 137  (29) 140  (28) 141  (34) 139  (34) 107  (21) 141  (23) 159  (33) 159  (30) 159  (25) 108  (23) 138  (27) 151  (23) 146  (22) 149  (25) 101  (19) 150  (36) 121  (26) 98  (16) 149  (28) 119  (16) 100  (19) 151  (36) 124  (27)
2.Secondary Outcome
Title Pain Scores
Hide Description VAS pain scoes at rest 0=no pain, 100=worst pain imaginable
Time Frame Patients were followed for the duration of hospitalization, for an average of 6 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo 0-4 Hours Dexamethasone 4 mg 0-4 Hours Dexamethasone 8 mg 0-4 Hours Placebo 8-24 Hours Dexamethasone 4 mg 8-24 Hours Dexamethasone 8 mg 8-24 Hours
Hide Arm/Group Description:
Placebo 0-4 hours baseline
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 33 32 31 34 32 33
Mean (Standard Deviation)
Unit of Measure: 0-100 VAS scale scores on a scale
50  (21) 47  (26) 45  (24) 50  (21) 45  (17) 44.5  (23)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Control-saline Group Dexamethasone Group
Hide Arm/Group Description [Not Specified] either 4 mg or 8 mg
All-Cause Mortality
Control-saline Group Dexamethasone Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Control-saline Group Dexamethasone Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/67 (0.00%)   0/128 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Control-saline Group Dexamethasone Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/67 (0.00%)   0/128 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Glenn S. Murphy, MD
Organization: NorthShore University HealthSystem
Phone: 847-570-2760
Responsible Party: Glenn S. Murphy, MD, NorthShore University HealthSystem Research Institute
ClinicalTrials.gov Identifier: NCT01545700     History of Changes
Other Study ID Numbers: EH08-413
First Submitted: February 27, 2012
First Posted: March 7, 2012
Results First Submitted: November 9, 2012
Results First Posted: January 15, 2013
Last Update Posted: January 18, 2013