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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Glenn S. Murphy, MD, NorthShore University HealthSystem Research Institute
ClinicalTrials.gov Identifier:
NCT01545700
First received: February 27, 2012
Last updated: January 15, 2013
Last verified: January 2013
Results First Received: November 9, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Postoperative Complications
Interventions: Drug: Control-saline
Drug: Dexamethasone 4 mg
Drug: Dexamethasone 8 mg
Drug: Control saline

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 200 patients were enrolled in this clinical trial.

Reporting Groups
  Description
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


Participant Flow:   Overall Study
    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  
STARTED     34     33     33     34     33     33  
COMPLETED     33     32     31     34     32     33  
NOT COMPLETED     1     1     2     0     1     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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

Total Total of all reporting groups

Baseline Measures
    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  
Number of Participants  
[units: participants]
  34     33     33     34     33     33     200  
Age  
[units: participants]
             
<=18 years     0     0     0     0     0     0     0  
Between 18 and 65 years     29     29     30     25     28     28     169  
>=65 years     5     4     3     9     5     5     31  
Age  
[units: years]
Mean ± Standard Deviation
  53  ± 10     53  ± 9     53  ± 11     57  ± 12     53  ± 13     56  ± 11     54  ± 9  
Gender  
[units: participants]
             
Female     34     33     33     34     33     33     200  
Male     0     0     0     0     0     0     0  
Region of Enrollment  
[units: participants]
             
United States     34     33     33     34     33     33     200  



  Outcome Measures
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1.  Primary:   Serum Blood Glucose Concentrations   [ Time Frame: Patient were followed for the duration of hospitalization, for an average of 6 days ]

2.  Secondary:   Pain Scores   [ Time Frame: Patients were followed for the duration of hospitalization, for an average of 6 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
None


  More Information
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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
e-mail: dgmurphy2@yahoo.com


No publications provided


Responsible Party: Glenn S. Murphy, MD, NorthShore University HealthSystem Research Institute
ClinicalTrials.gov Identifier: NCT01545700     History of Changes
Other Study ID Numbers: EH08-413
Study First Received: February 27, 2012
Results First Received: November 9, 2012
Last Updated: January 15, 2013
Health Authority: United States: Institutional Review Board