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

History of Changes

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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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 ]

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2. Secondary:

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

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Limitations and Caveats

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

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

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